Skip to content

Colposcopically Directed Ob/Gyn Laser

by Photon Sources

510(k) K761347

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK761347 Date18 Jan 1977ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
HHR
Device Class
Class II
Regulation
21 CFR Part 884.4550
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 Colposcopically Directed Ob/Gyn Laser is a surgical laser device designed for use in gynecological procedures. It functions as an energy source that generates a beam of photons to perform surgical interventions in the vagina, vulva, and extragenital areas.

This device is regulated under the Obstetrics/Gynecology medical specialty and is identified by product code HHR. It has received FDA 510(k) clearance under K761347. The device is classified as a Class 2 surgical laser under regulation number 884.4550.

Other devices from Photon Sources