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Ktp Disc Kit

by Laserscope

510(k) K905424

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 NumberK905424 Date4 Mar 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  • Withdrawn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)

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, 24 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 Ktp Disc Kit is a powered laser surgical instrument. It is classified as a medical device under the product code GEX and is used in general and plastic surgery. The device is substantially equivalent to other devices on the market.

The Ktp Disc Kit is supplied by Laserscope and has been assigned the k number K905424. It is a class 2 device and is regulated under the code 878.4810. The device was cleared on March 4, 1991, and is intended for use in surgical procedures.

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Questions

AI-generated answers, 24 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 KTP Disc Kit used for?

    The KTP Disc Kit is used in general and plastic surgery for surgical procedures, as it is a powered laser surgical instrument.

  • How is the KTP Disc Kit supplied?

    The KTP Disc Kit is supplied by Laserscope, the manufacturer of the device, and has been assigned the k number K905424.

  • Is the KTP Disc Kit a single-use or reusable device?

    The device data does not specify whether the KTP Disc Kit is single-use or reusable, but it is classified as a class 2 device.

  • What is the regulatory classification of the KTP Disc Kit?

    The KTP Disc Kit is regulated under the code 878.4810 and has been cleared by the FDA, with a decision description of Substantially Equivalent.