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Model 2100 Nd:Yag Surgical Laser Neurosurgical Ind

by Sharplan Industries, Inc.

510(k) K861044

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 NumberK861044 Date28 Oct 1986ClearedStatusActive

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  • Withdrawn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.

The Model 2100 Nd:Yag Surgical Laser Neurosurgical Ind is a surgical laser device. It is classified under the product code GEX. The device is a type of Nd:Yag laser, which is used for surgical procedures.

The device is supplied by Sharplan Industries, Inc. It has been found to be substantially equivalent. The device has the k number K861044 and is used in neurosurgical indications. The storage and size details are not specified, but the device has been reviewed by the advisory committee SU.

Other devices from Sharplan Industries, Inc.

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 Model 2100 Nd:Yag Laser used for?

    The Model 2100 Nd:Yag Laser is used for neurosurgical indications, providing a precise and effective tool for surgical procedures.

  • Who manufactures the Model 2100 Nd:Yag Laser?

    The Model 2100 Nd:Yag Laser is manufactured by Sharplan Industries, Inc.

  • What is the product code for the Model 2100 Nd:Yag Laser?

    The Model 2100 Nd:Yag Laser is classified under the product code GEX.

  • What is the k number for the Model 2100 Nd:Yag Laser?

    The k number for the Model 2100 Nd:Yag Laser is K861044.