K240222
- 510(k) number
- K240222
- Device name
- Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024)
- Applicant
- Aesthetic Technology, Ltd. GB
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2024-06-04
- Date received
- 2024-01-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K240222.pdf
Official FDA record: K240222
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.