Cleared Traditional

OLIZ LTB-1000A

K221189 · Ltbio Co., Ltd. · Physical Medicine

Aug 2022

Decision

126d

Days

Class 2

Risk

About This 510(k) Submission

K221189 is an FDA 510(k) clearance for the OLIZ LTB-1000A, a Lamp, Infrared, Therapeutic Heating (Class II — Special Controls, product code ILY), submitted by Ltbio Co., Ltd. (Seongnam-Si, KR). The FDA issued a Cleared decision on August 29, 2022, 126 days after receiving the submission on April 25, 2022. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5500.

Submission Details

510(k) Number	K221189 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 25, 2022
Decision Date	August 29, 2022
Days to Decision	126 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF