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Ace-Tec SR11CM4

by Guangdong Ace-Tec Co., Ltd.

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 Number06920473100868 UDI-DI Date15 Jan 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  • Withdrawn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
Ace-Tec
Generic Name
Blue/red/infrared phototherapy lamp
Model / Reference
SR11CM4
Primary DI / UDI-DI
06920473100868
510(k) Number
FDA Product Code
OHS, OLP
GMDN Term
Blue/red/infrared phototherapy lamp
Device Class
Class II
Regulation Number
878.4810
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K252994)

Other devices from Guangdong Ace-Tec Co., Ltd.

See all devices from Guangdong Ace-Tec Co., Ltd. →

Properties

  • Over-the-Counter
  • Lot / Batch Number
  • Serial Number

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No
  • Manufacturing Date: No