LASER HELMET— 510(k) K122950
Substantially EquivalentTheradome, Inc.
FDA 510(k) clearance K122950 for LASER HELMET, Substantially Equivalent on 2013-06-14. Applicant: Theradome, Inc.. Device class: 2.
Clearance details
- Applicant
- Theradome, Inc.
- Product code
- Code OAP
- Device class
- Class 2
- Regulation
- 21 CFR 890.5500
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pleasanton, CA, US
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