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LightScalpel LS-20111-01

by Lightscalpel Inc

LightScalpel LS-20111-01 is a laser adaptor (FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument) made by Lightscalpel Inc, cleared under FDA 510(k) K141658 on 22 Oct 2014 and listed in FDA GUDID since 3 Nov 2016 (UDI-DI 00851842007319), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K141658

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00851842007319 UDI-DI Date3 Nov 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK141658 Date22 Oct 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K141658 decided 22 Oct 2014 Active
  • FDA GUDID UDI-DI 00851842007319 listed 3 Nov 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K141658
  2. Listed FDA GUDID 00851842007319

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
LightScalpel
Generic name
Laser adaptor
Model / Ref / Catalog
LS-20111-01, 20111-01
Primary DI / UDI-DI
00851842007319
510(k) Number
FDA product code
GEX
GMDN term
Laser adaptor
Device class
Class II
Regulation number
878.4810
GUDID distribution status
In Commercial Distribution

Related devices

Category: Laser adaptor

Cleared under the same submission (K141658)

and 8 more cleared under K141658

Similar devices

Other devices filed under FDA product code GEX (Powered Laser Surgical Instrument).

Other devices from Lightscalpel Inc

See all devices from Lightscalpel Inc →

Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)