FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Hair Laser Headband
K Number: K182501
·
Decision Oct 26, 2018
Classifications
1
FEI Numbers
67
Registration Numbers
67
Same Product Code
109
Applicant Total
3
Review Days
44
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Basic Information
- Device Name
- Hair Laser Headband
- K Number
- K182501
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 890.5500
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pulsaderm, LLC
- Date Received
- September 12, 2018
- Decision Date
- October 26, 2018
- 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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