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Omniplus Photosurgical Laser System for OB-GYN

by Laserscope

510(k) K863221

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 NumberK863221 Date2 Mar 1987ClearedStatusActive

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  • Withdrawn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, 20 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 Omniplus Photosurgical Laser System for OB-GYN is a surgical laser classified as a Laser, Surgical, Gynecologic. It is designed for precise tissue ablation, coagulation, and vaporisation in gynecological procedures, utilising laser energy to achieve controlled surgical outcomes.

This system is intended for use in clinical settings by trained medical professionals. It is supplied as a reusable medical device and has received FDA 510(k) clearance under product code HHR, with a decision date of March 2, 1987. The device falls under regulation 884.4550 and is intended for obstetrics and gynecology applications, as reviewed by the Obstetrics/Gynecology advisory committee.

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