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Original Penguin STONTO52

by Kenmark Optical Co., Inc.

Original Penguin STONTO52 is a Class I device made by Kenmark Optical Co., Inc., listed in FDA GUDID since 12 Aug 2021 (UDI-DI 00715317220774), registry data as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00715317220774 UDI-DI Date12 Aug 2021ListedStatusListed 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  • Withdrawn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

Trade name
Original Penguin
Generic name
Prescription spectacles
Model / reference
STONTO52
Primary DI / UDI-DI
00715317220774
FDA product code
HQZ
GMDN term
Prescription spectacles
Device class
Class I
Regulation number
886.5842
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code HQZ (Frame, spectacle).

Other devices from Kenmark Optical Co., Inc.

See all devices from Kenmark Optical Co., Inc. →

Properties

  • Over-the-counter
  • Premarket exempt
Other properties (13, all answered No)