FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ULTRAVIOLET TREATMENT LAMPS UV-8 & UV-9
K Number: K852534
·
Decision Nov 8, 1985
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
271
Applicant Total
13
Review Days
147
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Basic Information
- Device Name
- ULTRAVIOLET TREATMENT LAMPS UV-8 & UV-9
- K Number
- K852534
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4630
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- R. A. Fischer Co. Corp.
- Date Received
- June 14, 1985
- Decision Date
- November 8, 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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Other Clearances by R. A. Fischer Co. Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K964208 | MD-1A GALVANIC UNIT | Apr 30, 1997 | Substantially Equivalent |
| K954031 | COMPU-BLEND EPILATOR | Jan 5, 1996 | Substantially Equivalent |
| K895365 | MD-2 IONTOPHORESIS UNIT | Jun 26, 1990 | Unknown |
| K893389 | MODEL SE-5 EPILATOR | Jun 5, 1989 | Substantially Equivalent |
| K884079 | MODEL CBX EPILATOR | Oct 4, 1988 | Substantially Equivalent |
| K871372 | CB-7 ELECTRONIC EPILATOR | Apr 28, 1987 | Substantially Equivalent |
| K843063 | ELECTRONIC EPILATOR TS-1 | Sep 26, 1984 | Substantially Equivalent |
| K823674 | HIGH FREQUENCY EPILATOR CB-2 | Jan 14, 1983 | Substantially Equivalent |
| K801351 | EPILATOR, MODEL CP-16 | Jul 28, 1980 | Substantially Equivalent |
| K780076 | EPILATOR, ELECTRONIC MODEL SE-2 | Jan 24, 1978 | Substantially Equivalent |