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Portable Light Source F0063873L1

by Optim LLC

Portable Light Source F0063873L1 is a Class II device made by Optim LLC, cleared under FDA 510(k) K091829 on 28 Jul 2009 and listed in FDA GUDID since 19 Sep 2016 (UDI-DI 00858119004101), 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) K091829

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 Number00858119004101 UDI-DI Date19 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Abbreviated NumberK091829 Date28 Jul 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K091829 decided 28 Jul 2009 Active
  • FDA GUDID UDI-DI 00858119004101 listed 19 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K091829
  2. Listed FDA GUDID 00858119004101

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Portable Light Source
Generic name
Endoscopic light source unit, battery-powered
Model / reference
F0063873L1
Primary DI / UDI-DI
00858119004101
510(k) Number
FDA product code
NTN
GMDN term
Endoscopic light source unit, battery-powered
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution

Other devices from Optim LLC

See all devices from Optim LLC →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)