FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Laser Helmet LH40-EVO
K Number: K161046
·
Decision May 12, 2016
Classifications
1
FEI Numbers
67
Registration Numbers
67
Same Product Code
109
Applicant Total
5
Review Days
29
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Basic Information
- Device Name
- Laser Helmet LH40-EVO
- K Number
- K161046
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 890.5500
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Theradome, Inc.
- Date Received
- April 13, 2016
- Decision Date
- May 12, 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 |
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