Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T505KQ, T505KH, T505KF, SL-B505WM)
FDA 510(k) clearance K253881 · decided 2025-12-29
Clearance details
- K-number
- K253881
- Device name
- Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T505KQ, T505KH, T505KF, SL-B505WM)
- Applicant
- Shenzhen Fansizhe Science and Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2025-12-04
- Decision date
- 2025-12-29
- Days to decision
- 25 days
- Clearance type
- Special
- 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.