FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LASER HELMET
K Number: K122950
·
Decision Jun 14, 2013
Classifications
1
FEI Numbers
67
Registration Numbers
67
Same Product Code
109
Applicant Total
5
Review Days
262
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- LASER HELMET
- K Number
- K122950
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5500
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Theradome, Inc.
- Date Received
- September 25, 2012
- Decision Date
- June 14, 2013
- 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.
Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159)
FDA 510(k)
FDA Class 2
·Physical Medicine
Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500)
FDA 510(k)
FDA Class 2
·Physical Medicine
Alma TED+ System
FDA 510(k)
FDA Class 2
·Physical Medicine
TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300)
FDA 510(k)
FDA Class 2
·Physical Medicine
Hair Regrowth Cap (Model: T-119-HRC)
FDA 510(k)
FDA Class 2
·Physical Medicine
Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1)
FDA 510(k)
FDA Class 2
·Physical Medicine