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Lasers

GentleMax Pro Plus

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
GentleMax, GentleMax Pro, Candela GentleMax, alexandrite laser hair removal

FDA status

Pathway
FDA-cleared device (510(k)) — cleared, not approved
First approved or cleared
Not confirmed — see the research notes

Research notes

K201111 cleared 2020-05-26 (21 CFR 878.4810, product code GEX). The label defines permanent hair reduction as a long-term, stable reduction in the number of hairs regrowing measured at 6, 9 and 12 months after a treatment regime; it is not the same as permanent hair removal. openFDA lists earlier GentleMax family clearances (e.g., 2011, 2013, 2014) that were not opened, so the first authorization year is not recorded here.

What it’s authorized for

As recorded from the FDA record and labeling cited below.

  • 755 nm (alexandrite): temporary hair reduction, and stable long-term or permanent hair reduction, on all skin types (Fitzpatrick I-VI) including tanned skin
  • 755 nm: benign pigmented lesions, wrinkles, and vascular lesions such as port-wine stains, hemangiomas and telangiectasias
  • 1064 nm (Nd:YAG): removal of unwanted hair for stable long-term or permanent hair reduction and treatment of pseudofolliculitis barbae (razor bumps), on all skin types including tanned skin
  • 1064 nm: pigmented and vascular lesions (such as spider and leg veins, rosacea, warts), coagulation of soft tissue, benign pigmented lesions, and reduction of black or blue-black tattoo intensity

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 K201111, 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 K201111 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: K201111 (GentleMax Pro Plus) (opens in a new tab)FDA database
  2. FDA 510(k) clearance letter and Indications for Use, K201111 (opens in a new tab)FDA database

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

Treatments that use it

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.

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