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Depilase Twin YAG Laser System

by Depilase Group, Ltd. 2 variants

510(k) K030510

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK030510 Date14 May 2003ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GEX
FDA applicant
Depilase Group , Ltd.
Device Class
Class II
Regulation
21 CFR Part 878.4810
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Depilase Twin YAG Laser System is a flashlamp-pumped Nd:YAG laser (Product Code: GEX) designed for dermatological applications. It emits laser radiation at 1064 nm, with an optional Second Harmonic Crystal (SHC) module to generate 532 nm output, enabling precise tissue interaction for surgical procedures in general and plastic surgery.

This device is intended for single-use or reusable (as per manufacturer specifications) in controlled clinical settings, with no explicit MRI safety restrictions noted. Supplied as a sterile or non-sterile system (sterility not confirmed in data), it requires proper storage and handling per regulatory guidelines. Authorised under FDA 510(k) clearance (K020697) as substantially equivalent, it falls under Class II classification for powered laser surgical instruments.

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