FDA Device Establishments · JSON-LD · Markdown
FEI 3021349626 · Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device · Status: Active
| FEI Number | 3021349626 |
|---|---|
| Owner / Operator | Lumenis Be Ltd. (#10082799) |
| Address | 9 Hakidma St, POB # 426, Yokneam Industrial Park, Yokneam, Ha Zafon 2069236 Haifa, 2069236, IL |
| Mandatory US Agent | Lumenis Be Inc |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | GEX |
| Regulation § (21 CFR) | 878.4810 |
| Proprietary names | UltraPulse Encore; UltraScan CPG; DeepFX Microscanner; TrueSpot Collimated 2 mm Handpiece; Focused Incisional Handpiece Set |
Source: openFDA. Public-domain (CC0).