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Optical Biometer Argos

by Santec Corporation

Optical Biometer Argos is a Class II device made by Santec Corporation, cleared under FDA 510(k) K150754 on 2 Oct 2015 and listed in FDA GUDID since 1 May 2017 (UDI-DI 04573344510017), 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) K150754

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 Number04573344510017 UDI-DI Date1 May 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK150754 Date2 Oct 2015IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K150754 decided 2 Oct 2015 Active
  • FDA GUDID UDI-DI 04573344510017 listed 1 May 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K150754
  2. Listed FDA GUDID 04573344510017

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Optical Biometer
Generic name
Bench-top keratometer
Model / reference
ARGOS
Primary DI / UDI-DI
04573344510017
510(k) Number
FDA product code
MXK
GMDN term
Bench-top keratometer
Device class
Class II
Regulation number
886.1850
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Bench-top keratometer

Similar devices

Other devices filed under FDA product code MXK (Device,Analysis,Anterior Segment).

Properties

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