K242197
- 510(k) number
- K242197
- Device name
- IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max)
- Applicant
- Shenzhen Huaruibo Electric Appliances Co., Ltd. CN
- Product code
- OHT — Light Based Over-The-Counter Hair Removal
- Decision date
- 2024-10-17
- Date received
- 2024-07-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
510(k) Summary (official FDA PDF): K242197.pdf
Official FDA record: K242197
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.