LightScalpel LS-4020

• FDA 510(k) K213669 decided 15 Feb 2023 Active· +3 more in the status table
• FDA GUDID UDI-DI 00851842007623 listed 26 Jun 2023 Listed

1. 29 Nov 2012 Cleared FDA 510(k) K123037
2. 2 Jan 2014 Cleared FDA 510(k) K132661
3. 22 Oct 2014 Cleared FDA 510(k) K141658
4. 15 Feb 2023 Cleared FDA 510(k) K213669
5. 26 Jun 2023 Listed FDA GUDID 00851842007623

Trade name

LightScalpel

Generic name

Dermatological carbon dioxide laser system

Model / Ref / Catalog

LS-4020, LS9032-01, LS9038-01

Primary DI / UDI-DI

00851842007623

510(k) Number

K123037 ↗

K132661 ↗

K141658 ↗

K213669 ↗

FDA product code

GEX

GMDN term

Dermatological carbon dioxide laser system

Device class

Class II

Regulation number

878.4810

GUDID distribution status

In Commercial Distribution

Category: Dermatological carbon dioxide laser system

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• 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 →