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Bare Fiber 600 T Luer Lock LGO-Bare Fiber Single Use

by Light Guide Optics International SIA

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04053002150415 UDI-DI Date14 Aug 2026ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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 — GUDID listing Listed

Specification

GUDID

Trade Name
Bare Fiber 600 T Luer Lock
Generic Name
General/multiple surgical laser system beam guide, single-use
Model / Ref / Catalog
LGO-Bare Fiber Single Use, USBFCS000302
Primary DI / UDI-DI
04053002150415
510(k) Number
FDA Product Code
GEX
GMDN Term
General/multiple surgical laser system beam guide, single-use
Device Class
Class II
Regulation Number
878.4810
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Related devices

Cleared under the same submission (K243147)

Other devices from Light Guide Optics International SIA

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No