FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COHERENT FLOUROTRON MASTER
K Number: K811153
·
Decision Jun 16, 1981
Classifications
1
FEI Numbers
54
Registration Numbers
55
Same Product Code
107
Applicant Total
43
Review Days
50
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Basic Information
- Device Name
- COHERENT FLOUROTRON MASTER
- K Number
- K811153
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1850
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Lumenis, Inc.
- Date Received
- April 27, 1981
- Decision Date
- June 16, 1981
- Product Code
- HJO
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | FDA class 2 | Ophthalmic |
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