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Kaplan Pendulaser 115 - A 15W CO2 Surgical Laser

by Optomedic Medical Technologies, Ltd.

510(k) K950313

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 NumberK950313 Date24 Mar 1995ClearedStatusActive

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  • Withdrawn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
FDA applicant
Optomedic Medical Technologies , Ltd.
Device Class
Class II
Regulation
21 CFR Part 878.4810
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 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 Kaplan Pendulaser 115 is a 15W CO2 surgical laser. It is substantially equivalent to a predicate device and has received FDA 510(k) clearance under product code GEX.

The device is indicated for use in general and plastic surgery applications. It is supplied by Optomedic Medical Technologies, Ltd. and was cleared via the traditional 510(k) pathway.

Other devices from Optomedic Medical Technologies, Ltd.

Questions

AI-generated answers, 6 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 Kaplan Pendulaser 115 used for?

    The Kaplan Pendulaser 115 is indicated for use in general and plastic surgery applications as a 15W CO2 surgical laser, based on its FDA 510(k) clearance for these surgical procedures.

  • How is the Kaplan Pendulaser 115 supplied and by whom?

    The Kaplan Pendulaser 115 is supplied by Optomedic Medical Technologies, Ltd., as stated in the device authorization and manufacturer information.

  • What regulatory pathway was used for the Kaplan Pendulaser 115?

    The Kaplan Pendulaser 115 received FDA 510(k) clearance through the traditional 510(k) pathway, as indicated by its clearance type and authorization details.