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Sharplan Model 3100 Nd:YAG Surgical Laser System

by Sharplan Lasers, Inc.

510(k) K951165

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 NumberK951165 Date12 Jun 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  • Withdrawn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
Device Class
Class II
Regulation
21 CFR Part 878.4810
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

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

This device is a powered laser surgical instrument classified under the GEX product code. It is a Sharplan Model 3100 Nd:YAG surgical laser system designed for use in surgical procedures.

It received FDA 510(k) clearance K951165 on June 12, 1995, as a substantially equivalent device. The system is intended for general and plastic surgery applications and is classified as a Class II device with special controls.

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Questions

AI-generated answers, 27 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 Sharplan Model 3100 Nd:YAG surgical laser system used for?

    The Sharplan Model 3100 Nd:YAG surgical laser system is designed for use in general and plastic surgery procedures, as indicated in its FDA 510(k) clearance documentation for surgical laser applications.

  • How was the Sharplan Model 3100 Nd:YAG laser system cleared for market?

    The device received FDA 510(k) clearance under K951165 on June 12, 1995, as a substantially equivalent device to a previously cleared laser system, following a traditional review pathway.

  • What regulatory classification applies to the Sharplan Model 3100 Nd:YAG laser?

    The Sharplan Model 3100 Nd:YAG surgical laser system is classified as a Class II device under the GEX product code, which requires special controls as part of its regulatory pathway.