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MedLite Q-Switched Nd:YAG Laser, MedLite IV Q-Switched Nd:YAG Laser

by Continuum Biomedical, Inc.

510(k) K973719

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 NumberK973719 Date23 Dec 1997ClearedStatusActive

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  • Withdrawn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

Overview

AI-generated summary, 1 Oct 2026

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

The MedLite Q-Switched Nd:YAG Laser is a Q-switched neodymium-doped yttrium aluminum garnet (Nd:YAG) laser system classified under product code GEX. This device emits laser energy at 1064 nm, designed for selective targeting of hair follicles to facilitate hair removal or lightening in clinical settings.

Intended for use by healthcare professionals, the MedLite Q-Switched Nd:YAG Laser is supplied for clinical environments and has received FDA 510(k) clearance (K973719) under the General, Plastic Surgery advisory committee. The device operates as a reusable medical instrument and is not described as single-use or sterile upon supply. No additional regulatory or sterility details are provided beyond its clearance status.

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Questions

AI-generated answers, 1 Oct 2026

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

  • What is the MedLite Q-Switched Nd:YAG Laser used for?

    The MedLite Q-Switched Nd:YAG Laser is designed for selective targeting of hair follicles to facilitate hair removal or lightening in clinical environments. Its 1064 nm wavelength allows precise energy delivery to treat unwanted hair growth under professional supervision.

  • Is the MedLite Q-Switched Nd:YAG Laser reusable or single-use?

    The MedLite Q-Switched Nd:YAG Laser is supplied as a reusable medical instrument. It is not described as single-use, meaning it is intended for repeated use in clinical settings after proper cleaning and maintenance.

  • What regulatory clearance does this device hold?

    The MedLite Q-Switched Nd:YAG Laser has received FDA 510(k) clearance under the General, Plastic Surgery advisory committee. The clearance number is K973719, and it was determined to be substantially equivalent to a predicate device.

  • How is the MedLite Q-Switched Nd:YAG Laser supplied?

    This device is supplied for clinical environments and is not described as sterile upon delivery. It is intended for use by healthcare professionals in professional settings, where sterility can be maintained through standard medical device protocols.

  • What wavelength does the MedLite Q-Switched Nd:YAG Laser emit?

    The MedLite Q-Switched Nd:YAG Laser emits laser energy at a wavelength of 1064 nm, which is optimized for selective targeting of hair follicles during hair removal or lightening procedures.