IPL Hair Removal Device, model(s): S1-A, S2-A, S1, S2, S3, S4
FDA 510(k) clearance K220222 · decided 2022-04-26
Clearance details
- K-number
- K220222
- Device name
- IPL Hair Removal Device, model(s): S1-A, S2-A, S1, S2, S3, S4
- Applicant
- Shenzhen Yuwei Electronic Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2022-01-26
- Decision date
- 2022-04-26
- Days to decision
- 90 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.