510(k) clearance
Picosecond Laser treatment system (Z180)
- 510(k) number
- K262628
- Applicant
- Sanhe PERFECTLASER Technology Co., Ltd.
- Decision date
- Oct 20, 2026
- Date received
- Jul 29, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- GEX
- Device type
- Powered Laser Surgical Instrument
- Device class
- Class II
- Regulation
- 21 CFR 878.4810
- Advisory committee
- General, Plastic Surgery
- Statement or summary
- Summary
- Third party
- N
- Location
- Langfang, CN