Part of the PicoSure and Pico Lasers guide · 1 articles

PicoSure Tattoo Removal: Faster Than Q-Switched?

PicoSure is Cynosure's 755 nm picosecond laser, cleared by FDA 510(k) for tattoo and benign pigmented lesion removal. Its picosecond pulses were expected to fragment ink more effectively than the nanosecond pulses of Q-switched lasers. A 2016 systematic review found only "sparse evidence" that they do — mainly for black and blue ink. Here is what the evidence says about picosecond lasers like PicoSure, and what it does not say.

PicoSure (Cynosure)Device755 nm Alexandrite picosecond laser; optional 532/1064 nm
510(k)-clearedFDA statusClass II laser instrument — cleared, not FDA-approved
SparseEvidence vs Q-switched2016 review of 6 trials, 160 participants
MultipleSessions neededink is layered; the body clears ink between sessions

Key takeaways

  • PicoSure is 510(k)-cleared for tattoo removal, not FDA-approved: it is a Class II laser instrument.
  • A 2016 review found only "sparse evidence" that picosecond lasers beat Q-switched lasers, mainly for black and blue ink.
  • No verified source shows PicoSure clears tattoos in fewer sessions; multiple sessions are needed with any laser.
  • Ink color and skin type together decide what a given machine is cleared to treat.
  • Prices scale with tattoo size and vary by location; we found no national average for PicoSure specifically.

How PicoSure removes ink

PicoSure is Cynosure's 755 nm Alexandrite picosecond laser, with optional 532 nm and 1064 nm delivery systems.

The FDA has cleared it by 510(k) for tattoo and benign pigmented lesion removal — the current clearance, K261570, is dated June 17, 2026, and the first, K121346, November 27, 2012.

Cleared is not approved: like PicoWay and PiQo4, it is regulated as a Class II "powered laser surgical instrument" (21 CFR 878.4810), a device category the FDA clears rather than approves.

The cleared 755 nm indication covers tattoo and benign pigmented lesion removal, and its text specifically lists melasma, nevus of Ota and nevus of Hori among those lesions.

PicoSure's 2 mm and 6 mm handpieces and its Focus Array are cleared for acne scars and wrinkles in skin types I–IV; those uses sit alongside the 755 nm tattoo indication, not within it.

The working theory behind the device is that tattoo pigment particles have a thermal relaxation time under 10 nanoseconds, so pulses measured in picoseconds were expected to fragment ink more effectively than the nanosecond pulses of Q-switched lasers.

<10 nsThermal relaxation time of tattoo pigment particlesThe rationale for picosecond pulses; Reiter et al., Lasers Med Sci, 2016

The laser breaks the ink; your body does the clearing.

The American Academy of Dermatology (AAD) explains that tattoo ink is applied in layers, that a laser cannot safely break down all the layers in one session, and that the body — not the laser — clears the shattered ink particles between sessions.

That is why multiple sessions are needed; the AAD's explanation is about laser tattoo removal generally, not one device.

The full session-by-session process is covered in our laser tattoo removal guide.

Side effects and pigment change

Reported side effects of picosecond tattoo removal in the 2016 review included pain, hyperpigmentation and hypopigmentation, blistering, transient redness, swelling and pinpoint bleeding; the review gives no rates for them. The AAD says light or dark spots after laser tattoo removal tend to disappear within 6 to 12 months, and that people who are pregnant or breastfeeding should not be treated.

Fewer sessions vs Q-switched?

Shorter pulses should, in theory, fragment ink more effectively — that expectation is the stated rationale for picosecond lasers.

The 2016 systematic review (Reiter et al., Lasers Med Sci) put it to the numbers across 6 human trials with 160 participants.

Its conclusion: "sparse evidence" that picosecond lasers beat nanosecond Q-switched lasers, mainly for black and blue ink.

The range the review reports is this: 69–100% of tattoos reached more than 70% clearance after 1 to 10 sessions.

The review's limits matter as much as its conclusion.

The included studies were mostly non-comparative and carried a medium-to-high risk of bias.

69–100%Of tattoos reached more than 70% clearanceReiter et al., 2016; mostly non-comparative studies
1–10Sessions to reach that clearanceReiter et al., 2016

For session counts, that means there is no verified answer.

Mostly non-comparative trials cannot establish that PicoSure — or any picosecond laser — clears tattoos in fewer sessions than a Q-switched laser.

Multiple sessions are the constant: the AAD's explanation — ink sits in layers, and the body clears what the laser breaks up between sessions — is not tied to one device.

Watch session-count claims

Claims that PicoSure removes tattoos in half the sessions of Q-switched lasers are not supported by the systematic evidence, which is sparse and mostly non-comparative. Ask any practice quoting a fixed session count how they arrived at it.

Which colors respond

Where the review found an edge for picosecond lasers, it was mainly for black and blue ink — and even that evidence is "sparse." Beyond that, we could not find a source that ranks ink colors for PicoSure specifically.

What the sources do show is that each device's clearance assigns ink colors to specific wavelengths — and, as the AAD puts it, no single laser can remove all ink colors.

PicoSure's cleared wavelengths are 755 nm as standard, with optional 532 nm and 1064 nm delivery systems.

The FDA documents we reviewed for PicoSure do not break ink colors down wavelength by wavelength, and its optional 532 nm delivery is cleared only for skin types I–III.

PicoWay's 510(k) (K220853, October 13, 2022) spells the color logic out.

It covers four wavelengths — 1064, 532, 730 and 785 nm — at pulse durations of 240 to 500 picoseconds, and names ink colors for each: 1064 nm for black, brown, green, blue and purple ink in all Fitzpatrick skin types; 532 nm for red, yellow and orange in types I–III; 730 and 785 nm for green and blue.

PiQo4, cleared in 2015 (K151473) as the NaturaLase PiQo4 from Focus Medical, is a Q-switched Nd:YAG 1064 nm laser with 532 nm optics and a pulse-slicing module; the FDA document lists its pulse duration as about 450–500 ps.

Its cleared tattoo use follows the same split: 1064 nm for black, brown, green, blue and purple in all skin types, and 532 nm for red, yellow and orange in types I–III.

Ink colors named in the PicoWay and PiQo4 clearances

WavelengthPicoWay (K220853)PiQo4 (K151473)
1064 nmBlack, brown, green, blue, purple; all skin typesBlack, brown, green, blue, purple; all skin types
532 nmRed, yellow, orange; skin types I–IIIRed, yellow, orange; skin types I–III
730 / 785 nmGreen, blueNot offered

Two patterns are worth taking to a consultation.

First, the evidence for a picosecond edge sits in black and blue ink: the review's advantage was mainly for those colors.

Second, warm inks are where skin type bites: PicoWay and PiQo4 assign red, yellow and orange to 532 nm, cleared for those colors only in skin types I–III, and PicoSure's optional 532 nm delivery carries the same I–III limit — though its FDA documents do not name ink colors per wavelength.

Ink color and skin type together decide what a given machine is cleared to treat.

PicoWay's clearance also reaches beyond tattoos, to melasma and lentigines in skin types I–IV, café-au-lait macules, nevus of Ota (1064 nm, skin types III–IV) and, with its Resolve handpieces, acne scars and wrinkles.

The platform-wide picture, including PicoSure's cleared uses beyond tattoo removal, is in our PicoSure (pico laser) guide.

Find pico laser providers near you

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Cost per session

Laser tattoo removal can be charged per session, and the price can scale with the size of the tattoo.

The one pricing structure our sources show in detail is the chain LaserAway's own: its site said, when we read it on October 16, 2026, that it prices laser tattoo removal by tattoo size — five options ranging from Quarter to Full Page — with a choice of a single treatment or a package of 3, 10 or 16.

The listed prices included $200 per treatment for a quarter-size tattoo ($82 per treatment in a 16-pack) and $420 per treatment for dollar-bill size ($169 per treatment in a 16-pack).

That is one chain's own pricing: it shows the mechanics — size tiers, per-session charges, package discounts — not a market average, it is not specific to PicoSure, and LaserAway says its prices vary by location.

LaserAway listed tattoo removal prices (read Oct 16, 2026; vary by location)

Tattoo sizeSingle treatmentPer treatment in a 16-pack
Quarter$200$82
Dollar bill$420$169

National numbers are weaker than they look.

ASPS's tattoo removal cost page says the average cost of laser skin treatments like laser tattoo removal is $697 "according to the latest statistics." Read closely, it is a weak figure: ASPS shows the same generic number on its laser hair removal page, it is a plastic-surgeon fee, and the page does not say whether it is per session — it does not state the statistics year either.

We found no national average price for PicoSure tattoo removal specifically: RealSelf's PicoSure "average cost" page could not be read during our research (access denied), so no RealSelf figure exists in our sources.

What moves the total: the number of sessions your tattoo needs — in the studies behind the 2016 review, 69–100% of tattoos reached more than 70% clearance after 1 to 10 sessions, and the AAD's explanation for why several are needed is that ink sits in layers and the body clears the shattered ink between visits; the ink colors and your skin type, since the clearances limit some wavelengths to certain skin types; and how the practice prices — per session, by size tier, or in packages.

Questions worth asking before you book: what one session costs and what it includes; whether the price varies with the size of the tattoo, and whether a package changes the per-session price; how many sessions they estimate for your tattoo's colors and your skin type; which wavelengths their PicoSure carries (755 nm is standard, 532 nm and 1064 nm are optional); and what happens if the tattoo needs more visits than the estimate.

Frequently asked questions

Is PicoSure FDA-approved for tattoo removal?

No. PicoSure is FDA 510(k)-cleared, not approved: like PicoWay and PiQo4, it is regulated as a Class II "powered laser surgical instrument" (21 CFR 878.4810).

Its clearance record runs from K121346 in 2012 to K261570, dated June 17, 2026, covering tattoo and benign pigmented lesion removal.

Our research verified those clearances, not every PicoSure-branded model a practice might advertise, so ask which device you would be treated on and what its clearance covers.

Is PicoSure the same as PicoWay?

No. Both are picosecond-category lasers cleared for tattoo removal, but they are different products from different makers.

PicoSure is Cynosure's 755 nm Alexandrite laser with optional 532 nm and 1064 nm delivery.

PicoWay is Candela's, delivering 1064, 532, 730 and 785 nm at pulse durations of 240 to 500 picoseconds, with ink colors named for each wavelength in its clearance.

Both are 510(k)-cleared Class II devices, not FDA-approved.

How many sessions does PicoSure tattoo removal take?

No source gives a verified session count for PicoSure specifically.

The 2016 systematic review of picosecond tattoo removal reported 69–100% of tattoos reaching more than 70% clearance after 1 to 10 sessions, but its trials were mostly non-comparative.

The American Academy of Dermatology explains why multiple sessions are needed: ink is layered, a laser cannot safely break down all the layers in one session, and the body clears the shattered ink between visits.

Ask a practice for an estimate on your tattoo.

Do light or dark spots after laser tattoo removal go away?

The American Academy of Dermatology says light or dark spots that appear after laser tattoo removal tend to disappear within 6 to 12 months.

Pigment change is among the reported side effects of picosecond tattoo removal, alongside pain, blistering, transient redness, swelling and pinpoint bleeding; the research review reports no rates for them.

If you notice skin changes after a session, contact the practice that treated you.

Who should not have laser tattoo removal?

The American Academy of Dermatology says people who are pregnant or breastfeeding should not be treated, and that a healthy immune system is needed.

Its explanation of how removal works: the body — not the laser — clears the shattered ink particles between sessions.

The AAD's guidance is about laser tattoo removal generally — it is not written for one device.

Give the practice your full medical history before booking so a licensed provider can weigh your situation.

Sources

Every number on this page comes from one of these sources and was checked against it.

  1. accessdata.fda.gov · U.S. Food and Drug Administration
  2. accessdata.fda.gov · U.S. Food and Drug Administration
  3. accessdata.fda.gov · U.S. Food and Drug Administration
  4. Picosecond lasers for tattoo removal: a systematic review · Reiter et al., Lasers Med Sci, 2016
  5. Tattoo removal: Lasers outshine other methods · American Academy of Dermatology
  6. LaserAway Treatment Prices · laseraway.com
  7. Tattoo Removal Cost · American Society of Plastic Surgeons

Medical disclaimer. MedSpaStandard is for education only and is not medical advice. Talk to a licensed provider about your own health, and check any provider's license with your state board.