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Sunoptic Technologies Headlight Cables

by Sunoptic Technologies

Sunoptic Technologies Headlight Cables is a Class II device made by Sunoptic Technologies, cleared under FDA 510(k) K901035 on 23 Apr 1990 and listed in FDA GUDID since 9 May 2017 (UDI-DI M678HLC0), active as of 23 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 23 Oct 2026

Documents

510(k) K901035

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberM678HLC0 UDI-DI Date9 May 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK901035 Date23 Apr 1990DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K901035 decided 23 Apr 1990 Active
  • FDA GUDID UDI-DI M678HLC0 listed 9 May 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K901035
  2. Listed FDA GUDID M678HLC0

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Sunoptic Technologies
Generic name
Fibreoptic light cable, reusable
Model / reference
Headlight Cables
Primary DI / UDI-DI
M678HLC0
510(k) Number
FDA product code
FST, EQH
GMDN term
Fibreoptic light cable, reusable
Device class
Class II
Regulation number
878.4580, 874.4350
GUDID distribution status
In Commercial Distribution

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Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)