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Optos OCT/SLO

by Optos Public Limited Company

Optos OCT/SLO (000385) is a Class II device made by Optos Public Limited Company, cleared under FDA 510(k) K080460 on 14 Nov 2008 and listed in FDA GUDID since 23 Nov 2016 (UDI-DI 05057056003856), active as of 22 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 22 Oct 2026

Documents

510(k) K080460

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05057056003856 UDI-DI Date23 Nov 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK080460 Date14 Nov 2008DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K080460 decided 14 Nov 2008 Active
  • FDA GUDID UDI-DI 05057056003856 listed 23 Nov 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K080460
  2. Listed FDA GUDID 05057056003856

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Scanning-laser retinal imaging system
Model / Ref / Catalog
OCT, 000385
Primary DI / UDI-DI
05057056003856
510(k) Number
FDA product code
OBO
GMDN term
Scanning-laser retinal imaging system
Device class
Class II
Regulation number
886.1570
GUDID distribution status
In Commercial Distribution

Related devices

Category: Scanning-laser retinal imaging system

Similar devices

Other devices filed under FDA product code OBO (Tomography, Optical Coherence).

Other devices from Optos Public Limited Company

See all devices from Optos Public Limited Company →

Properties

  • Convenience kit
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)