K241116
- 510(k) number
- K241116
- Device name
- Onycho Laser V
- Applicant
- Terasysd&C, Inc. KR
- Product code
- PDZ — Lasers For Temporary Increase Of Clear Nail In Patie
- Decision date
- 2024-07-22
- Date received
- 2024-04-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K241116.pdf
Official FDA record: K241116
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.