510(k) K161046— Laser Helmet LH40-EVO
Substantially EquivalentTheradome, Inc.
Clearance details
- Applicant
- Theradome, Inc.
- Product code
- Code OAP
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Pleasanton, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.