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IwavePhoropter

by Krypton Vision (Suzhou) Ltd.

IwavePhoropter is a Class I device made by Krypton Vision (Suzhou) Ltd., listed in FDA GUDID since 23 Oct 2017 (UDI-DI 06971053610017), registry data as of 21 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 21 Oct 2026.

Regulatory status

as of registry sync 21 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06971053610017 UDI-DI Date23 Oct 2017ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic name
Phoropter
Model / reference
IwavePhoropter
Primary DI / UDI-DI
06971053610017
FDA product code
HKN, HKO
GMDN term
Phoropter
Device class
Class I
Regulation number
886.1770, 886.1760
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Related devices

Category: Phoropter

Similar devices

Other devices filed under FDA product code HKN (Refractor, Manual, Non-Powered, Including Phoropter).

Properties

  • Premarket exempt
Other properties (14, all answered No)