FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
IPL Hair Removal Device, Model(s): BSXT101, BSXT102, BSXT103, BSXT105, BSXT106, BSXT108
K Number: K230097
·
Decision Apr 6, 2023
Classifications
1
FEI Numbers
90
Registration Numbers
91
Same Product Code
161
Applicant Total
5
Review Days
83
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Basic Information
- Device Name
- IPL Hair Removal Device, Model(s): BSXT101, BSXT102, BSXT103, BSXT105, BSXT106, BSXT108
- K Number
- K230097
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shenzhen Bsx Technology Electronics Co., Ltd.
- Date Received
- January 13, 2023
- Decision Date
- April 6, 2023
- Product Code
- OHT
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OHT | Light Based Over-The-Counter Hair Removal | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OHT), ordered by most recent decision date.
Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
IPL Hair Removal Device (FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG, FL-B507AP, FL-B507AM, FL-B508AG, FL-B508AP, FL-B508AM, FL-B509AG, FL-B509AP, FL-B509AM, FL-B510G, FL-B510P, FL-B510M, FL-B511G, FL-B511P, FL-B511M, FL-B512AG, FL-B512AP, FL-B512AM, FL-B513AG, FL-B513AP, FL-B513AM)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
IPL Hair Removal (SL-B301, SL-B300, SL-B330, SL-B330-1, SL-B287-1, SL-B371, SL-B371-2, SL-B371-1, SL-B352, SL-B352-1, SL-B352-2, SL-B330-F)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Hair Removal Device (CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07, CTU09, CTU012, CTU015, CTU X, DT015 Pro, DT015, DT017 Pro, DT017, DT025 Pro, DT025)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
IPL Hair Removal Device (Models: T31A, T32A)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Shenzhen Bsx Technology Electronics Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K241578 | Wrist Digital Blood Pressure Monitor (BSX312, BSX313, BSX315, BSX322, BSX323, BSX353, BSX355) | Feb 19, 2025 | Substantially Equivalent |
| K202296 | Infrared Forehead Thermometer, Model BSX976 | Jul 23, 2021 | Substantially Equivalent |
| K202324 | Fingertip Pulse Oximeter | Dec 14, 2020 | Substantially Equivalent |
| K183058 | Arm-type Electronic Blood Pressure Monitor | Jul 3, 2019 | Substantially Equivalent |