IPL Hair Removal, Model(s): SB01, SB01A, SB01B, SB01C, SN02, SN03— 510(k) K223524
Substantially EquivalentMorlaser Shenzhen Co., Ltd.
FDA 510(k) clearance K223524 for IPL Hair Removal, Model(s): SB01, SB01A, SB01B, SB01C, SN02, SN03, Substantially Equivalent on 2023-02-16. Applicant: Morlaser Shenzhen Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Morlaser Shenzhen 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
view all- K262352 — IPL Hair Removal Device (AHR01, R3C16-G Pro1, AHR02, AHR03, R4820, R6715, L3B02, JR20, R6312, R6202)
- K261975 — Braun Aura 7 (6041)
- K261977 — Braun Aura 9 (6042)
- 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)
Data sourced from openFDA. This site is unofficial and independent of the FDA.