Skip to content

Laserscope KTP/532 And Ktp/Yag Surgical Laser

by Laserscope

510(k) K911830

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 NumberK911830 Date14 Aug 1991ClearedStatusActive

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  • Withdrawn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)

Full name
Laserscope(R) Ktp/532 and Ktp/Yag Surgical Laser
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, 22 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 Laserscope Ktp/532 And Ktp/Yag Surgical Laser is a powered laser surgical device. It is designed for multiple specialty applications, including general surgery, plastic surgery, and orthopedics. The device has a dual wavelength output, allowing for separate tissue interactions. It is used for various surgical procedures.

The device is supplied as a single unit and is intended for use in a clinical setting. It has received FDA 510K clearance, with the clearance number K911830. The device is classified under the product code GEX, with a regulation number of 878.4810. It is stored and used according to standard surgical laser protocols.

Other devices from Laserscope

See all devices from Laserscope →

Questions

AI-generated answers, 22 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 Laserscope KTP/532 laser used for?

    The Laserscope KTP/532 laser is used for various surgical procedures, including general surgery, plastic surgery, and orthopedics, due to its dual wavelength output allowing for separate tissue interactions.

  • How is the device supplied?

    The Laserscope KTP/532 laser is supplied as a single unit, intended for use in a clinical setting, and is stored according to standard surgical laser protocols.

  • What is the regulatory status of the device?

    The device has received FDA 510K clearance, with the clearance number K911830, indicating it is substantially equivalent to a predicate device.

  • What are the storage and usage protocols for the device?

    The device is stored and used according to standard surgical laser protocols, ensuring safe and effective operation in a clinical setting.