Skip to content

Ar-1600g Auto-Refractometer

by Nidek, Inc.

510(k) K902500

Ar-1600g Auto-Refractometer is a medical device (FDA Class I; FDA product code HKO, Refractometer, Ophthalmic) made by Nidek, Inc., cleared under FDA 510(k) K902500 on 27 Jul 1990, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK902500 Date27 Jul 1990ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
HKO
Device class
Class I
Regulation
21 CFR Part 886.1760
Advisory committee
Ophthalmic
FDA decision
SESE Substantially Equivalent

Similar devices

Other devices filed under FDA product code HKO (Refractometer, Ophthalmic).

Other devices from Nidek, Inc.

See all devices from Nidek, Inc. →