510(k) K242197
K242197 is an FDA 510(k) premarket notification submitted by Shenzhen Huaruibo Electric Appliances Co., Ltd. for the device "IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max)". The FDA issued a decision of Substantially Equivalent on October 17, 2024. The device falls under product code OHT (Light Based Over-The-Counter Hair Removal), a Class II device regulated under 21 CFR 878.4810.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 17, 2024
- Date Received
- July 26, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light Based Over-The-Counter Hair Removal
- Device Class
- Class II
- Regulation Number
- 878.4810
- Review Panel
- SU
- Submission Type
Over-the-counter device uses thermal energy to kill hair follicles for hair removal.