FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ULTRALITE HF1236 HAND AND FOOT SYSTEM
K Number: K861963
·
Decision Jun 25, 1986
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
271
Applicant Total
6
Review Days
36
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Basic Information
- Device Name
- ULTRALITE HF1236 HAND AND FOOT SYSTEM
- K Number
- K861963
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4630
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Ultralite
- Date Received
- May 20, 1986
- Decision Date
- June 25, 1986
- 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 Ultralite
| K Number | Device Name | ||
|---|---|---|---|
| K910091 | ULTRALITE PANELITE | May 30, 1991 | Substantially Equivalent |
| K820492 | SPECTRA305 | Mar 31, 1982 | Substantially Equivalent |
| K827123 | SPECTRA (ULTRAVIOLET PRODUCTS) | Mar 5, 1982 | Substantially Equivalent |
| K820280 | SPECTRA 305/350 | Mar 5, 1982 | Substantially Equivalent |
| K761179 | PSORALITE | May 3, 1977 | Substantially Equivalent |