Oliz LTB-1000A
FDA 510(k) K221189 · Ltbio Co., Ltd.
510(k) numberK221189
Submission
- Device name
- Oliz LTB-1000A
- Applicant
- Ltbio Co., Ltd.
Seongnam-Si, KR - Received
- April 25, 2022
- Decision date
- August 29, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ILY – Lamp, Infrared, Therapeutic Heating
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5500
- Specialty
- Physical Medicine
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Questions and answers
When was Oliz LTB-1000A cleared by the FDA?
Oliz LTB-1000A (K221189) received a 510(k) decision of Substantially Equivalent on August 29, 2022, 126 days after the submission was received.
What is the product code of K221189?
The FDA product code is ILY – Lamp, Infrared, Therapeutic Heating, a Class II (moderate risk) device regulated under 21 CFR 890.5500.