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TearCare(TM) System Kit FG 05509

by Sight Sciences, Inc.

TearCare(TM) System Kit FG 05509 (5-100) is a Class II device made by Sight Sciences, Inc., listed in FDA GUDID since 16 Mar 2018 (UDI-DI 00858027006242), not in commercial distribution (GUDID) as of 22 Oct 2026.

Listed FDA GUDID listing, not in commercial distribution

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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00858027006242 UDI-DI Date16 Mar 2018ListedStatusListed GUDID: not in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
TearCare(TM) System Kit
Generic name
Eyelid heat therapy system control unit
Model / Ref / Catalog
FG 05509, 5-100
Primary DI / UDI-DI
00858027006242
FDA product code
IRT
GMDN term
Eyelid heat therapy system control unit
Device class
Class II
Regulation number
890.5740
GUDID distribution status
Not in Commercial Distribution

Other devices from Sight Sciences, Inc.

See all devices from Sight Sciences, Inc. →

Properties

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