FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
SOLARC / SOLRX HANDHELD ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY
K Number: K061589
·
Decision Aug 4, 2006
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
271
Applicant Total
4
Review Days
57
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Basic Information
- Device Name
- SOLARC / SOLRX HANDHELD ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY
- K Number
- K061589
- 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 8, 2006
- Decision Date
- August 4, 2006
- 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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Other Clearances by Solarc Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K103204 | SOLARC / SOLRX E-SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY | Apr 27, 2011 | Substantially Equivalent |
| K031800 | SOLARC/SOLRX 500 SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY A NEW MEDICAL DEVICE FAMILY CONSISTING OF 5 MODELS: | Sep 10, 2003 | Substantially Equivalent |
| K935572 | SOLARC 1000 SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT | Mar 7, 1994 | Substantially Equivalent |