FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
308nm Excimer System
K Number: K192642
·
Decision May 13, 2020
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
271
Applicant Total
4
Review Days
232
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Basic Information
- Device Name
- 308nm Excimer System
- K Number
- K192642
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4630
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Chongqing Peninsula Medical Technology Co., Ltd.
- Date Received
- September 24, 2019
- Decision Date
- May 13, 2020
- Product Code
- FTC
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FTC | Light, Ultraviolet, Dermatological | FDA class 2 | General, Plastic Surgery |
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