FDA 510(k)
FDA class 1
Substantially Equivalent
🇩🇪 Germany
COLD LIGHT SOURCE LOS 150
K Number: K951829
·
Decision Jul 10, 1995
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
48
Applicant Total
4
Review Days
81
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Basic Information
- Device Name
- COLD LIGHT SOURCE LOS 150
- K Number
- K951829
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4350
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Laser-Optik-Systeme GmbH & Co. KG
- Date Received
- April 20, 1995
- Decision Date
- July 10, 1995
- Product Code
- EQH
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| EQH | Source, Carrier, Fiberoptic Light | FDA class 1 | Ear, Nose, Throat |
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