510(k) K221523
K221523 is an FDA 510(k) premarket notification submitted by Unilam Co., Ltd. for the device "Tanning Lamp". The FDA issued a decision of Substantially Equivalent on Feb 15, 2023. The device falls under product code LEJ (Booth, Sun Tan), a Class II device regulated under 21 CFR 878.4635. Unilam Co., Ltd. has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 15, 2023
- Date Received
- May 26, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Booth, Sun Tan
- Device Class
- Class II
- Regulation Number
- 878.4635
- Review Panel
- SU
- Submission Type
- 510(k)