PicoSure and Pico Lasers: Pigment, Tattoos and Skin Revitalization

PicoSure is a picosecond laser made by Cynosure, built around a 755 nm Alexandrite laser with optional 532 nm and 1064 nm delivery systems.

The FDA first cleared it on 27 November 2012 under K121346, and its most recent clearance, K261570 on 17 June 2026, covers tattoo and benign pigmented lesion removal.

The "pico" refers to the pulse length: picosecond pulses are shorter than the nanosecond pulses of older Q-switched lasers.

The reasoning, as a 2016 systematic review describes it, is that tattoo pigment particles have a thermal relaxation time under 10 nanoseconds, so picosecond pulses were expected to fragment ink more effectively than nanosecond Q-switched pulses.

Regulatory status matters here: PicoSure, PicoWay and PiQo4 are all FDA 510(k)-cleared Class II "powered laser surgical instruments" under 21 CFR 878.4810 — cleared devices, not FDA-approved drugs.

A 510(k) clearance covers the indications written into it, so when a med spa offers PicoSure, the question to ask is whether the use being sold is one of the cleared ones.

PicoSure's clearance names its uses and skin types specifically, and both determine candidacy.

• Tattoo and benign pigmented lesion removal is a cleared use of the 755 nm laser.
• The cleared 755 nm indication explicitly includes melasma, along with nevus of Ota and nevus of Hori.
• The 2 mm and 6 mm handpieces and the Focus Array are cleared for acne scars and wrinkles in skin types I–IV.
• The 532 nm delivery system is cleared for skin types I–III only.

So candidacy is a matching exercise: the target has to fall inside a cleared indication, and the skin type has to fall inside the clearance for the wavelength that would be used.

A use outside the cleared indications is not a cleared use for this device, whatever a treatment menu calls it.

For laser tattoo removal specifically, the American Academy of Dermatology (AAD) says people who are pregnant or breastfeeding should not be treated, and that a healthy immune system is needed, because the body — not the laser — clears the shattered ink between sessions.

We could not confirm a national average price for PicoSure treatment, so this page does not quote one; ask each provider you are considering for a written quote.

What the quote turns on comes straight from the clearances and the studies:

• The use: tattoo removal, pigment work and the acne-scar/wrinkle handpieces are different cleared uses with different treatment plans.
• The session count: the AAD explains that tattoo removal is built as a series because ink is layered, a laser cannot safely break down all the layers in one session, and the body clears the shattered ink between sessions.
• How far the series runs: in the six human trials covered by the 2016 systematic review (160 participants), 69–100% of tattoos reached more than 70% clearance after 1–10 sessions.
• Skin type and ink colors, which decide which wavelengths a clearance allows for you.

For melasma specifically, the AAD notes treatment is generally not considered medically necessary, so most insurers will not cover it.

A single price you see online is worth treating with caution unless it names the provider, the city and the date — and a per-session price is not the same figure as a full treatment plan.

Session counts and result duration depend on which cleared use you are talking about.

For tattoos, the AAD explains that multiple sessions are needed because the artist layers the ink, a laser cannot safely break down all the layers in one treatment session, and the body clears the shattered ink particles between sessions; a single laser also cannot remove all ink colors.

In the trials covered by the 2016 systematic review, 69–100% of tattoos reached more than 70% clearance after 1–10 sessions — trial conditions, different lasers and mostly non-comparative designs, so a research range rather than a personal estimate.

The session-by-session process, including what changes the count, is covered in our guide to laser tattoo removal.

For age spots, the AAD says one or two laser treatments can treat them quickly with longer-lasting results than creams — a statement about laser treatment of age spots generally, not PicoSure specifically — though lasers can cause crusting or temporary darkening, and spots can return without sun protection.

For melasma, the AAD says adding laser or light treatment improved results in a few studies among people already using topical medication and sun protection, and that melasma treatment usually takes 3 to 12 months to show results.

Duration is the weak point for melasma: a 2022 systematic review (Neagu et al., Journal of Dermatological Treatment) reports that recurrence rates remain high with all melasma treatments, that no single treatment is universally effective, and that combination therapies gave the best results.

Pain was on the list of reported side effects of picosecond tattoo removal in the 2016 systematic review, but the review gave no rates — so this evidence cannot tell you how painful a session is.

We could not confirm a standard pain-management approach for PicoSure treatments, so ask a provider directly what numbing or cooling they use, and for which areas.

On recovery, the reported effects included transient redness, swelling and pinpoint bleeding, with blistering also reported; the review gave neither rates nor recovery times, so we cannot confirm a downtime figure for this device from the research we use.

One after-effect does have a published course: the AAD says light or dark spots after laser tattoo removal tend to disappear within 6 to 12 months, and that treated skin should be protected from the sun for 3 months.

The side effects reported in the 2016 systematic review of picosecond tattoo removal were:

• Pain
• Hyperpigmentation (dark spots) and hypopigmentation (light spots)
• Blistering
• Transient redness and swelling
• Pinpoint bleeding

The review reported no frequencies for these, so none of them can honestly be called common or rare on this evidence.

The color-change effects have the clearest published course: the AAD says light or dark spots after laser tattoo removal tend to disappear within 6 to 12 months.

The skin-type limits in the clearances are worth checking against your own skin before booking: PicoSure's 532 nm delivery is cleared only for skin types I–III, and its acne-scar/wrinkle handpieces for skin types I–IV.

The other "pico" brand names are cleared for different things, which matters more than the marketing around them.

• PicoWay (Candela) delivers 1064, 532, 785 and 730 nm at pulse durations of 240–500 picoseconds. Its 510(k) (K220853, 13 October 2022) clears tattoo removal by ink color and skin type: 1064 nm for black, brown, green, blue and purple ink in all Fitzpatrick types; 532 nm for red, yellow and orange in types I–III; 730/785 nm for green and blue. It is also cleared for melasma (532/1064 nm, types I–IV), lentigines (532/730 nm, types I–IV), café-au-lait macules, nevus of Ota (1064 nm, types III–IV) and, with its Resolve fractional handpieces, acne scars and wrinkles.
• PiQo4 was cleared in 2015 (K151473) as the NaturaLase PiQo4 from Focus Medical — a Q-switched Nd:YAG 1064 nm laser with 532 nm optics and a pulse-slicing module, listed at about 450–500 picoseconds — and its cleared use is tattoo removal only.

The practical split: PicoSure and PicoWay carry pigment, acne-scar and wrinkle clearances, while PiQo4's cleared use is tattoo removal only; the wavelength menus also differ, with PicoSure cleared at 755 nm plus optional 532 and 1064 nm.

Against older Q-switched lasers, the 2016 systematic review found only "sparse evidence" that picosecond lasers perform better, mainly for black and blue ink.

For how the two compare on tattoos, see PicoSure laser tattoo removal.

Against light-based devices: ASPS defines intense pulsed light (IPL) as a non-laser light treatment that emits multiple wavelengths converted to heat to target pigment, blood vessels and hair follicles.

For sun spots (solar lentigines), a 2025 systematic review of 41 trials (3,234 patients) reported success ranges of 74.6–90% for IPL, 67.9–93.02% for picosecond laser, 36.36–76.6% for Q-switched laser and 37–71.4% for cryotherapy — ranges drawn from different trials with different measures, not head-to-head comparisons, so they do not rank the options.

The same review found IPL and pulsed dye were less associated with post-inflammatory hyperpigmentation, and cryotherapy with more severe side effects.

Which device fits comes down to target, skin type and tattoo colors, and a licensed provider answers it after examining the area; our IPL photofacial and laser skin resurfacing guides cover the adjacent routes.

PicoSure is a brand-name device, so start by asking a practice which laser would actually treat you — device, handpiece and wavelength — and match the answer against the clearances above.

A use you cannot find in the device's clearance is not a cleared use, whatever the treatment menu calls it.

• Which device, handpiece and wavelength will treat me, and is my use one of its cleared indications?
• Is my skin type inside the clearance for that wavelength — for example, PicoSure's 532 nm delivery is cleared only for skin types I–III?
• If the target is an age spot, has a board-certified dermatologist examined it first? The AAD recommends a skin exam because what looks like an age spot could be skin cancer.
• What is the price per session, how many sessions does the plan expect, and what is the plan if the result falls short?

From there, the same vetting applies as for any med spa treatment: our how to choose a med spa checklist covers credentials, supervision, consults and written pricing in ten points.