Sls Chromos 694 Qd Ruby Laser to Be Renamed Mehl Qd Ruby Laser System for Hair Removal

by Classy Lady by Mehl of Puerto Rico, Inc.

510(k) K962109

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

510(k) K962109↗

FDA record

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

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK962109	Date13 Mar 1997Cleared	StatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K962109
FDA Product Code: GEX

Device Class: Class II
Regulation: 21 CFR Part 878.4810
Advisory Committee: General, Plastic Surgery
FDA Decision: SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Mehl QD Ruby Laser System for Hair Removal is a laser hair removal device designed to target and reduce unwanted hair through selective photothermolysis. It emits a quantum-dot (QD) ruby laser at a specific wavelength to selectively destroy hair follicles while preserving surrounding skin tissue, making it suitable for both facial and body hair removal procedures.

This device is intended for in-office use by trained medical professionals and is supplied as a reusable medical instrument. It is not sterile upon delivery and requires proper cleaning and maintenance as per manufacturer instructions. The system is FDA 510(k)-cleared under product code GEX and adheres to regulatory standards outlined in 21 CFR 878.4810. No MRI safety information is specified in the provided data.