FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LIGHT COMMANDER
K Number: K960767
·
Decision Aug 26, 1996
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
5
Applicant Total
5
Review Days
182
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Basic Information
- Device Name
- LIGHT COMMANDER
- K Number
- K960767
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4335
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Scieran Technologies, Inc.
- Date Received
- February 26, 1996
- Decision Date
- August 26, 1996
- Product Code
- FCT
- 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 |
|---|---|---|---|
| FCT | Headlight, Fiberoptic Focusing | FDA class 2 | Ophthalmic |
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