Laser Hair Therapy
FDA 510(k) clearance K183329 · decided 2019-01-16
Clearance details
- K-number
- K183329
- Device name
- Laser Hair Therapy
- Applicant
- Omm Imports, Inc. D/B/A Zero Gravity
- Decision
- Substantially Equivalent
- Date received
- 2018-11-30
- Decision date
- 2019-01-16
- Days to decision
- 47 days
- Clearance type
- Traditional
- Product code
- OAP
- Device class
- 2
- Regulation number
- 890.5500
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Hallandale, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Recreo Hair Growth Laser Comb recall (Z-1222-2023) | OMM Imports, Inc. dba Zero Gravity | 2023-03-14 |