510(k) K242349
- Device
- FoLix
- Applicant
- Lumenis Be, Ltd.
- 510(k) number
- K242349
- Product code
- GEX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-09-09
- Date received
- 2024-08-08
- Regulation
- 878.4810
- Classification name
- Powered Laser Surgical Instrument
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Shlomit Segman
- Address
- 9 Hakidma St. P.O. Box 426, Yokneam Industrial Park Yokneam IL 2069236 2069236
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Source Documents
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