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TracLux-SLS

by Sunoptic Technologies

TracLux-SLS (TLC1353-SLSU) is a Class II device made by Sunoptic Technologies, listed in FDA GUDID since 29 May 2023 (UDI-DI M678TLCSLS0), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberM678TLCSLS0 UDI-DI Date29 May 2023ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
TracLux
Generic name
Open surgical site internal light
Model / Ref / Catalog
TracLux-SLS, TLC1353-SLSU
Primary DI / UDI-DI
M678TLCSLS0
FDA product code
FSZ, FTD
GMDN term
Open surgical site internal light
Device class
Class II
Regulation number
878.4580
GUDID distribution status
In Commercial Distribution

Related devices

Category: Open surgical site internal light

Other devices from Sunoptic Technologies

See all devices from Sunoptic Technologies →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (7, all answered No)