Intense Pulsed Light (IPL) System— 510(k) K212881
Substantially EquivalentShenzhen Fansizhe Science and Technology Co., Ltd.
FDA 510(k) clearance K212881 for Intense Pulsed Light (IPL) System, Substantially Equivalent on 2022-04-11. Applicant: Shenzhen Fansizhe Science and Technology Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Shenzhen Fansizhe Science and Technology Co., Ltd.
- Product code
- Product code OHT
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Recent devices under product code OHT
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- K262524 — Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B, Ice 2.2B)
- K261705 — Hair Removal Device (R3C16-G Pro, R3C16-V Pro)
More clearances from Shenzhen Fansizhe Science and Technology Co., Ltd.
view all- K253881 — Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T505KQ, T505KH, T505KF, SL-B505WM)
- K251173 — Intense Pulsed Light (IPL) System (T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T002AQ, T002AD, T002AF, T002BQ, T002BD, T002BF, T050KQ, T050KD, T050KF)
- K223928 — Intense Pulsed Light (IPL) System, model: T023K, T023A, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T001N, T011C, T016K
- K221569 — Intense Pulsed Light (IPL) System, model: T013C, T015C, T015K
Data sourced from openFDA. This site is unofficial and independent of the FDA.