FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ULTRALITE PANELITE
K Number: K910091
·
Decision May 30, 1991
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
5
Applicant Total
6
Review Days
141
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Basic Information
- Device Name
- ULTRALITE PANELITE
- K Number
- K910091
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5500
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Ultralite
- Date Received
- January 9, 1991
- Decision Date
- May 30, 1991
- Product Code
- IOB
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| IOB | Lamp, Infrared, Non Heating | FDA class 2 | Physical Medicine |
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Other Clearances by Ultralite
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K820280 | SPECTRA 305/350 | Mar 5, 1982 | Substantially Equivalent |
| K761179 | PSORALITE | May 3, 1977 | Substantially Equivalent |