K230490
- 510(k) number
- K230490
- Device name
- PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA, 4004-LPUR-NA, 4004-CABLUE-NA-INT, 4004-GREY-INT, 4004-YELLOW-INT, 4004-PSTO-INT, 4004-LPUR-INT
- Applicant
- Dongguan Hunter Electronic Technology Co., Ltd. CN
- Product code
- OLP — Over-The-Counter Powered Light Based Laser For Acne
- Decision date
- 2023-10-27
- Date received
- 2023-02-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
510(k) Summary (official FDA PDF): K230490.pdf
Official FDA record: K230490
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.