FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
5031 BRIGHT FLASH STIMULATOR
K Number: K822915
·
Decision Dec 28, 1982
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
17
Applicant Total
68
Review Days
88
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Basic Information
- Device Name
- 5031 BRIGHT FLASH STIMULATOR
- K Number
- K822915
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1630
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Life-Tech Intl., Inc.
- Date Received
- October 1, 1982
- Decision Date
- December 28, 1982
- Product Code
- HLX
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| HLX | Photostimulator, Ac-Powered | FDA class 2 | Ophthalmic |
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