K242035
- 510(k) number
- K242035
- Device name
- Accure Laser System
- Applicant
- Accure Acne, Inc. CO · US
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2024-10-11
- Date received
- 2024-07-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K242035
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.