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Improvements to the Mehl Ruby Laser

by Mehl/Biophile Intl., Inc.

510(k) K971814

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 NumberK971814 Date1 Aug 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  • Withdrawn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, 26 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 Improvements to the Mehl Ruby Laser is a medical device used for the removal of unwanted body and facial hair. It operates at a wavelength of 694 nm and delivers specific energies to the skin to achieve hair removal.

This device is manufactured by Mehl/Biophile Intl., Inc. and received FDA 510(k) clearance on August 1, 1997, with K number K971814. It is substantially equivalent to its predecessor, the MEHL Ruby Laser for Hair Removal, and is constructed of similar components.

Other devices from Mehl/Biophile Intl., Inc.

Questions

AI-generated answers, 26 Sep 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 Improvements to the Mehl Ruby Laser used for?

    The Improvements to the Mehl Ruby Laser is a medical device specifically designed for the removal of unwanted body and facial hair. It operates at a wavelength of 694 nm to deliver specific energies to the skin to achieve hair removal results.

  • What is the regulatory status of this device?

    This device received FDA 510(k) clearance on August 1, 1997, with K number K971814. It is considered substantially equivalent to its predecessor, the MEHL Ruby Laser for Hair Removal, and is constructed of similar components.

  • Who manufactures the Improvements to the Mehl Ruby Laser?

    The device is manufactured by Mehl/Biophile Intl., Inc., located at 48 Mt. Olive Rd., Budd Lake, NJ 07828. The contact person for this device is Thomas Blake.

  • How does the Improvements to the Mehl Ruby Laser work?

    The device operates at a wavelength of 694 nm and delivers specific energies to the skin to target and remove unwanted hair. This technology allows for precise treatment of both body and facial hair with controlled energy delivery.