510(k) K230490
K230490 is an FDA 510(k) premarket notification submitted by Dongguan Hunter Electronic Technology Co., Ltd. for the device "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". The FDA issued a decision of Substantially Equivalent on October 27, 2023. The device falls under product code OLP (Over-The-Counter Powered Light Based Laser For Acne), a Class II device regulated under 21 CFR 878.4810. Dongguan Hunter Electronic Technology Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 27, 2023
- Date Received
- February 23, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Over-The-Counter Powered Light Based Laser For Acne
- Device Class
- Class II
- Regulation Number
- 878.4810
- Review Panel
- SU
- Submission Type
The device is intended for over-the-counter (otc) use to treat patients with mild to moderate acne vulgaris. The device is intended to emit energy in the red and blue region of the spectrum, specifically indicated to treat mild to moderate acne vulgaris.