LightScalpel H-S-T

• FDA 510(k) K141658 decided 22 Oct 2014 Active
• FDA GUDID UDI-DI 00851842007081 listed 24 Sep 2016 Listed

1. 22 Oct 2014 Cleared FDA 510(k) K141658
2. 24 Sep 2016 Listed FDA GUDID 00851842007081

Trade name

LightScalpel

Generic name

Laser adaptor

Model / Ref / Catalog

H-S-T, LS9002-06

Primary DI / UDI-DI

00851842007081

510(k) Number

K141658 ↗

FDA product code

GEX

GMDN term

Laser adaptor

Device class

Class II

Regulation number

878.4810

GUDID distribution status

In Commercial Distribution

Sterilisation method

Moist Heat or Steam Sterilization

Category: Laser adaptor

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• LASE SYSTEM II by Lase, Inc.
• 25GA Straight Laser Probe - Alcon PD725.10 by Peregrine Surgical, LLC.

• LightScalpel LS-20110-01

  Class II

  FDA 510(k) K141658 Active Cleared 22 Oct 2014 GUDID on market

• LightScalpel LSH-ADJ

  Class II

  FDA 510(k) K141658 Active Cleared 22 Oct 2014 GUDID on market

• LightScalpel LS-20111-01

  Class II

  FDA 510(k) K141658 Active Cleared 22 Oct 2014 GUDID on market

• LightScalpel LSA-TR

  Class II

  FDA 510(k) K141658 Active Cleared 22 Oct 2014 GUDID on market

See all devices from Lightscalpel Inc →