Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)
FDA 510(k) clearance K232117 · decided 2023-11-28
Clearance details
- K-number
- K232117
- Device name
- Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)
- Applicant
- Wuhan Lotuxs Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2023-07-17
- Decision date
- 2023-11-28
- Days to decision
- 134 days
- Clearance type
- Traditional
- Product code
- GEX
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Wuhan, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.