FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPECTRA 305/350
K Number: K820280
·
Decision Mar 5, 1982
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
7
Applicant Total
6
Review Days
31
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Basic Information
- Device Name
- SPECTRA 305/350
- K Number
- K820280
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4630
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Ultralite
- Date Received
- February 2, 1982
- Decision Date
- March 5, 1982
- Product Code
- KGL
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| KGL | Cabinet, Phototherapy (Puva) | 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 |
| K861963 | ULTRALITE HF1236 HAND AND FOOT SYSTEM | Jun 25, 1986 | Substantially Equivalent |
| K820492 | SPECTRA305 | Mar 31, 1982 | Substantially Equivalent |
| K827123 | SPECTRA (ULTRAVIOLET PRODUCTS) | Mar 5, 1982 | Substantially Equivalent |
| K761179 | PSORALITE | May 3, 1977 | Substantially Equivalent |