IPL Hair Removal Device, Model(s): T1, T2, T3, T7, T10
FDA 510(k) clearance K232183 · decided 2023-09-22
Clearance details
- K-number
- K232183
- Device name
- IPL Hair Removal Device, Model(s): T1, T2, T3, T7, T10
- Applicant
- Shenzhen Koli Technology Co.,Ltd
- Decision
- Substantially Equivalent
- Date received
- 2023-07-24
- Decision date
- 2023-09-22
- Days to decision
- 60 days
- Clearance type
- Traditional
- Product code
- OHT
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Shenzhen, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.