Skip to content

Ol-X30

by PENTAX of America Inc.

Ol-X30 is a Class II device made by PENTAX of America Inc., cleared under FDA 510(k) K172156 on 5 Apr 2018 and listed in FDA GUDID since 16 Apr 2018 (UDI-DI 04961333245222), active as of 8 Nov 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 8 Nov 2026

Documents

510(k) K172156

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04961333245222 UDI-DI Date16 Apr 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK172156 Date5 Apr 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K172156 decided 5 Apr 2018 Active
  • FDA GUDID UDI-DI 04961333245222 listed 16 Apr 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K172156
  2. Listed FDA GUDID 04961333245222

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
General-purpose light source
Model / reference
OL-X30
Primary DI / UDI-DI
04961333245222
FDA product code
PEA
GMDN term
General-purpose light source
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution

Related devices

Category: General-purpose light source

Cleared under the same submission (K172156)

and 8 more cleared under K172156

Similar devices

Other devices filed under FDA product code PEA (Endoscope, Accessories, Image Post-Processing For Color Enhancement).

Other devices from PENTAX of America Inc.

See all devices from PENTAX of America Inc. →

Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)