IPL Home Use Hair Removal Device (Models: FDA11, FDA12, FDA13, FDA14, FDA15, FDA16, FDA17, FDA18, FDA19, FDA20, FDA21S, FDA22S, FDA23S, FDA24S, FDA25, FDA26, FDA27, FDA28, FDA29S, FDA30S, FDA31S)
FDA 510(k) clearance K252234 · decided 2025-10-14
Clearance details
- K-number
- K252234
- Device name
- IPL Home Use Hair Removal Device (Models: FDA11, FDA12, FDA13, FDA14, FDA15, FDA16, FDA17, FDA18, FDA19, FDA20, FDA21S, FDA22S, FDA23S, FDA24S, FDA25, FDA26, FDA27, FDA28, FDA29S, FDA30S, FDA31S)
- Applicant
- Shenzhen Qiaochengli Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2025-07-17
- Decision date
- 2025-10-14
- Days to decision
- 89 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.