Skip to content

Eagle 420840010

by Belkin Vision, Ltd.

Eagle 420840010 is a Class II device made by Belkin Vision, Ltd., cleared under FDA 510(k) K230722 on 8 Dec 2023 and listed in FDA GUDID since 31 Jul 2024 (UDI-DI 07290018686027), 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) K230722

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 Number07290018686027 UDI-DI Date31 Jul 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK230722 Date8 Dec 2023DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K230722 decided 8 Dec 2023 Active
  • FDA GUDID UDI-DI 07290018686027 listed 31 Jul 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K230722
  2. Listed FDA GUDID 07290018686027

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Eagle
Generic name
Ophthalmic solid-state laser system
Model / reference
420840010
Primary DI / UDI-DI
07290018686027
510(k) Number
FDA product code
HQF
GMDN term
Ophthalmic solid-state laser system
Device class
Class II
Regulation number
886.4390
GUDID distribution status
In Commercial Distribution

Related devices

Category: Ophthalmic solid-state laser system

Cleared under the same submission (K230722)

Similar devices in this category

Other devices filed under Ophthalmic solid-state laser system.

Other devices from Belkin Vision, Ltd.

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)