Hair Growth System
FDA 510(k) clearance K191754 · decided 2019-11-22
Clearance details
- K-number
- K191754
- Device name
- Hair Growth System
- Applicant
- Kunshan Bella Optical Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2019-07-01
- Decision date
- 2019-11-22
- Days to decision
- 144 days
- Clearance type
- Traditional
- Product code
- OAP
- Device class
- 2
- Regulation number
- 890.5500
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Kunshan, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.