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Sign in to claim this brandCynosure, LLC
United States·US-MF-000010200
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 5, Carlisle Road, Westford, United States
- Website
- www.cynosurelutronic.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Nirav Desai
- EUDAMED SRN
- US-MF-000010200
- FDA FEI Number
- 1000120578
- DUNS Number
- 780318028
Catalogue (726)
Page 5 of 15| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Nubond Post | EPO1671 | FDA UDI | Class I | Active |
| ASSY, MASK, Petite, Submental Adapter | 100-7026-826 | FDA UDI | Class II | Active |
| Assy, Fnl Laser, Sculpsure, Sub Only Brazil | 100-7026-920 | FDA UDI | Class II | Active |
| Splint Mesh Stainless Steel Mesh Roll | ESG117 | FDA UDI | Class I | Active |
| Nubond Post Kit | EPO165 | FDA UDI | Class I | Active |
| Glass Fibre Post Kit | EGF200 | FDA UDI | Class I | Active |
| Remanufactured, Icon Laser System | R105-2500-000 | FDA UDI | Class II | Unknown |
| Roto-Pro Rotosonic | ERP103 | FDA UDI | Class I | Active |
| 15mm GlideSafe HP (3) and Cable | P215HPD | FDA UDI | Class II | Active |
| Suction Coag Tube | H47 | FDA UDI | Class II | Active |
| MaxG 4mm Adapter 5 pack | 2520-0035 | FDA UDI | Class II | Active |
| Extra-Large Grounding Pad, 25 Pcs | MEL-01221 | FDA UDI | Class II | Active |
| Nubond Post | EPO1672 | FDA UDI | Class I | Active |
| Roto-Pro Rotosonic | ERP105 | FDA UDI | Class I | Active |
| EMPIRE microIncision Needle Electrodes | TEE306 | FDA UDI | Class II | Active |
| MaxIR Handpiece, Remanufactured | 2520A-IR36R | FDA UDI | Class II | Active |
| Splint Grid Nylon Mesh Roll | ESG118 | FDA UDI | Class I | Active |
| Reamer | EPO1663 | FDA UDI | Class I | Active |
| Reamer | EPO1662 | FDA UDI | Class I | Active |
| Suction Handle | H78B | FDA UDI | Class I | Active |
| EMPIRE microIncision Needle Electrodes | TEE320 | FDA UDI | Class II | Active |
| Assy, Final Laser, Sculpsure, Sub Only | 100-7026-910 | FDA UDI | Class II | Active |
| Cosmetic Treatment Package | H135A | FDA UDI | Class II | Active |
| LuxY HP, Starlux | 1520-Y026 | FDA UDI | Class II | Active |
| Bipolar Cord | JX | FDA UDI | Class II | Active |
| 1540 Handpiece Icon, Remanufactured | 2520D-1540R | FDA UDI | Class II | Active |
| Roto-Pro Rotosonic | ERP102 | FDA UDI | Class I | Active |
| 585nm Dye Hanpiece, Gold | 100-7017-060 | FDA UDI | Class II | Active |
| Root-Cal | ERC137 | FDA UDI | Class II | Active |
| Surg-E-Vac Smoke Evacuation System | SVD220 | FDA UDI | Class II | Active |
| PelleFirm VariPack | P3PFVP-WMHU | FDA UDI | Class II | Active |
| Pv Glidesafe Hp | P215HPD | FDA UDI | Class II | Active |
| EMPIRE microIncision Needle Electrodes | QTEE312 | FDA UDI | Class II | Active |
| Pelleve GlideSafe 10MM HP, 1PC | P210HPD1 | FDA UDI | Class II | Active |
| ASSY, 30MM Massage Head, TempSure | 100-7027-056 | FDA UDI | Class II | Active |
| Radiolase 3 | RL3-D50/110 | FDA UDI | Class II | Active |
| LUXR HP, Starlux 500 | 5520-R026 | FDA UDI | Class II | Active |
| EMPIRE microIncision Needle Electrodes | TEE319 | FDA UDI | Class II | Active |
| Corneal Shields | H781 | FDA UDI | Class I | Active |
| 20mm Portrait Handpiece | 100-7027-120 | FDA UDI | Class II | Active |
| Vaginal Retractor | H69 | FDA UDI | Class I | Active |
| SculpSure laser assembly | 100-7026-010 | FDA UDI | Class II | Active |
| Ellman-Cot | H99 | FDA UDI | Class I | Active |
| Silicone Putty | ECM180 | FDA UDI | Class I | Active |
| Press Form Sheets, 0.30, 100 PCS | EPS1763 | FDA UDI | Class I | Active |
| Icon Control Module Reman | 2520-0003R | FDA UDI | Class II | Active |
| 1540 handpiece | 2520C-1540 | FDA UDI | Class II | Active |
| Bipolar Cord | IEC-JX/B | FDA UDI | Class II | Active |
| FlexSure Medium Applicator 10-Pack | ASY-14113 | FDA UDI | Class II | Active |
| Glidesafe Handpiece | P2VPHPD | FDA UDI | Class II | Active |
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Oct 9, 2014 | Z-0169-2015 | — | terminated | If the laser system is turned on and the user adjusts, installs or removes the XPL pulsed light handpiece, there is a potential risk of an electrical shock |