Skip to content
Spa Intelligence

Try a real question: “Who can inject Botox in Montana?” or “Is $12 per unit the full price?” The index loads on first use; what you type is matched in this browser.

Lasers

PicoWay

Candela Corporation

FDA-cleared device (510(k)) — cleared, not approvedChecked Sep 14, 2026 · Read on the pages cited

What it is

Maker
Candela Corporation
Category
Lasers
Also called
PicoWay Laser System, PicoWay Resolve, picosecond laser

FDA status

Pathway
FDA-cleared device (510(k)) — cleared, not approved
First approved or cleared
2015

Research notes

K220853 cleared 2022-10-13 (21 CFR 878.4810, product code GEX). Earliest PicoWay clearance opened: K150326, 2015-04-16 (Candela Corporation). Skin-type limits differ by wavelength and indication; the full list is in the Indications for Use form.

What it’s authorized for

As recorded from the FDA record and labeling cited below.

  • Tattoo removal, with wavelength and skin-type limits: 532 nm for red, yellow and orange ink (Skin Types I-III); 730 nm for green and blue ink (I-IV); 785 nm for green and blue ink (II-IV); 1064 nm for black, brown, green, blue and purple ink (all skin types)
  • Removal of benign pigmented lesions (Skin Types I-IV)
  • Resolve 1064 nm handpiece: acne scars (Skin Types II-V) and melasma (I-IV); Resolve handpieces: wrinkles (I-IV)
  • Specific wavelengths: melasma, café-au-lait macules and lentigines (532 nm); lentigines (730 nm); melasma and nevus of Ota (1064 nm), each with skin-type limits

How it’s sold

How it’s sold isn’t recorded for this entry.

What the label warns about

No label warning is recorded here. That isn’t the same as the label having none — the research notes and sources say what was opened.

Checking it’s the real thing

No FDA authenticity notice is recorded for this product.

Ask in the room

“What’s the brand name printed on the box, vial or device panel — and may I see it?”

Recalls and enforcement

FDA recall and enforcement records filed under K220853, read live from openFDA. A recall usually covers particular models or lots, not every unit ever made.

Searching FDA recall and enforcement records by this product’s FDA number…

Look up K220853 and a number from the box

Check it yourself

Device proof ladder: The room sells a laser, RF, microneedling, body-contouring, light, or other hardware result. Work down in order — each step needs the one before it.

  1. Read the panelGet the exact manufacturer and model from the device itself.
  2. Find the authorizationSearch 510(k) and De Novo by model/manufacturer, not treatment nickname.510(k) Premarket Notification database (opens in a new tab) · U.S. Food & Drug Administration
  3. Match identityUse AccessGUDID when a UDI or device identifier is available.AccessGUDID (opens in a new tab) · FDA / National Library of Medicine
  4. Read maker instructionsCompare the proposed use with current manufacturer labeling/IFU for that exact model.
  5. Check post-market recordSearch recalls/corrections after the model is known.Medical Device Recalls (opens in a new tab) · U.S. Food & Drug Administration
  6. Verify the operatorThen check the person's applicable state credential and device-specific training.

Worth knowing

What an FDA record can and can’t tell you

FDA records show what was authorized, for what, and when.

They can’t show that the product in the room is authentic, in date, stored properly, or being used for its authorized purpose. Those are questions for the room.

Sources

  1. FDA 510(k) database: K220853 (PicoWay Laser System) (opens in a new tab)FDA database
  2. FDA 510(k) clearance letter and Indications for Use, K220853 (opens in a new tab)FDA database
  3. FDA 510(k) database: K150326 (PicoWay Laser System) (opens in a new tab)FDA database

Checked Sep 14, 2026 · Read on the pages cited.

Treatments that use it

No treatment guide lists this product yet.

Product identity

Told a name? Shown a box?

Type what was said or printed, see whether it matches a registry entry, and note what you saw in your booking file.

Check a name