FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UV-A SUNTANNING EQUIPMENT
K Number: K853911
·
Decision Oct 21, 1985
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
271
Applicant Total
4
Review Days
31
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Basic Information
- Device Name
- UV-A SUNTANNING EQUIPMENT
- K Number
- K853911
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4630
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Eurotan Intl.
- Date Received
- September 20, 1985
- Decision Date
- October 21, 1985
- 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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