DermaScalp Laser Cap
FDA 510(k) clearance K152587 · decided 2016-02-04
Clearance details
- K-number
- K152587
- Device name
- DermaScalp Laser Cap
- Applicant
- Dermascalp, LLC
- Decision
- Substantially Equivalent
- Date received
- 2015-09-10
- Decision date
- 2016-02-04
- Days to decision
- 147 days
- Clearance type
- Traditional
- Product code
- OAP
- Device class
- 2
- Regulation number
- 890.5500
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Plano, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.