510(k) K192642
K192642 is an FDA 510(k) premarket notification submitted by Chongqing Peninsula Medical Technology Co., Ltd. for the device "308nm Excimer System". The FDA issued a decision of Substantially Equivalent on May 13, 2020. The device falls under product code FTC (Light, Ultraviolet, Dermatological), a Class II device regulated under 21 CFR 878.4630. Chongqing Peninsula Medical Technology Co., Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 13, 2020
- Date Received
- September 24, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light, Ultraviolet, Dermatological
- Device Class
- Class II
- Regulation Number
- 878.4630
- Review Panel
- SU
- Submission Type