Apoza LED 10W

by Apoza Enterprise Co., Ltd.

Apoza LED 10W is a Class II device made by Apoza Enterprise Co., Ltd., cleared under FDA 510(k) K041303 on 18 Jun 2004 and listed in FDA GUDID since 26 Jun 2023 (UDI-DI 04719883750624), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number04719883750624 UDI-DI	Date26 Jun 2023Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK041303	Date18 Jun 2004Decided	StatusActive

Official records

AccessGUDID record UDI-DI 04719883750624
FDA 510(k) database 510(k) number K041303

Across registries

2 registries list this device

FDA 510(k) K041303 decided 18 Jun 2004 Active
FDA GUDID UDI-DI 04719883750624 listed 26 Jun 2023 Listed

Timeline

2 dated events

18 Jun 2004 Cleared FDA 510(k) K041303
26 Jun 2023 Listed FDA GUDID 04719883750624

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Apoza
Generic name: Dental/surgical polymerization lamp
Model / reference: LED 10W

Primary DI / UDI-DI: 04719883750624
510(k) Number: K041303
FDA product code: EBZ
GMDN term: Dental/surgical polymerization lamp

Device class: Class II
Regulation number: 872.6070
GUDID distribution status: In Commercial Distribution

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Properties

Prescription use
Serial number
Manufacturing date

Other properties (12, all answered No)