FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
SOLARC/SOLRX 500 SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY A NEW MEDICAL DEVICE FAMILY CONSISTING OF 5 MODELS:
K Number: K031800
·
Decision Sep 10, 2003
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
269
Applicant Total
3
Review Days
91
Basic Information
- Device Name
- SOLARC/SOLRX 500 SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY A NEW MEDICAL DEVICE FAMILY CONSISTING OF 5 MODELS:
- K Number
- K031800
- 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
- SOLARC SYSTEMS, INC.
- Date Received
- June 11, 2003
- Decision Date
- September 10, 2003
- 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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