510(k) K221189
K221189 is an FDA 510(k) premarket notification submitted by Ltbio Co., Ltd. for the device "OLIZ LTB-1000A". The FDA issued a decision of Substantially Equivalent on August 29, 2022. The device falls under product code ILY (Lamp, Infrared, Therapeutic Heating), a Class II device regulated under 21 CFR 890.5500.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 29, 2022
- Date Received
- April 25, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lamp, Infrared, Therapeutic Heating
- Device Class
- Class II
- Regulation Number
- 890.5500
- Review Panel
- PM
- Submission Type