FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202
K Number: K160285
·
Decision Apr 25, 2016
Classifications
1
FEI Numbers
67
Registration Numbers
67
Same Product Code
109
Applicant Total
7
Review Days
82
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Basic Information
- Device Name
- Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202
- K Number
- K160285
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5500
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Capillus, LLC
- Date Received
- February 3, 2016
- Decision Date
- April 25, 2016
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OAP), ordered by most recent decision date.
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Other Clearances by Capillus, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K163170 | Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312, and Capillus 352 | Jan 31, 2017 | Substantially Equivalent |
| K162994 | Capillus302, Capillus312, Capillus352 | Nov 18, 2016 | Substantially Equivalent |
| K153618 | Capillus202 | Jan 19, 2016 | Substantially Equivalent |
| K151516 | Capillus82 | Aug 21, 2015 | Substantially Equivalent |
| K150578 | Capillus 272 Office Pro | Jun 9, 2015 | Substantially Equivalent |
| K143199 | Capillus 272 Pro | Jan 29, 2015 | Substantially Equivalent |