FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Capillus 112, Capillus 244
K Number: K192012
·
Decision Sep 12, 2019
Classifications
1
FEI Numbers
67
Registration Numbers
67
Same Product Code
109
Applicant Total
1
Review Days
45
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Basic Information
- Device Name
- Capillus 112, Capillus 244
- K Number
- K192012
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 890.5500
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Capillus
- Date Received
- July 29, 2019
- Decision Date
- September 12, 2019
- Product Code
- OAP
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| OAP | Laser, Comb, Hair | FDA class 2 | Physical Medicine |
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