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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 3 of 15| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Small Sapphire Optic | 3520A-0003 | FDA UDI | Class II | Active |
| Snare Wire | H7A | FDA UDI | Class II | Active |
| Suction Coag Tube 3 3/4" , 3/32" Caliber | H48 | FDA UDI | Class II | Active |
| LUXR HP, StarLux 500 Repl | 5520-R026R | FDA UDI | Class II | Active |
| ASSY, Full Body Kit With 60mm Kit | ASY-12943 | FDA UDI | Class II | Active |
| Surg-E-Vac Smoke Evacuation System | SVF1 | FDA UDI | Class II | Active |
| Ace-Tip Bipolar Forceps | ACBF-014 | FDA UDI | Class II | Active |
| FlexSure Large Applicator | ASY-14114 | FDA UDI | Class II | Active |
| Ellman-Cot | H98 | FDA UDI | Class I | Active |
| Spacer tip for 532 Handpiece | 130-7012-490 | FDA UDI | Class II | Active |
| Press Form Sheets | EPS351 | FDA UDI | Class I | Active |
| ASSY, Body Accessory Kit, TempSure | 100-7027-070 | FDA UDI | Class II | Active |
| Tip, Spacer, Dye Handpiece | 130-7017-015 | FDA UDI | Class II | Active |
| Pv Glidesafe Hp | P220HPD | FDA UDI | Class II | Active |
| Skintel Melanin Reader | 2520B-0038 | FDA UDI | Class II | Active |
| Iec Neutral Plate | IEC-NPC | FDA UDI | Class II | Active |
| Ace-Tip Bipolar Forceps | ACBF-021 | FDA UDI | Class II | Active |
| Ace-Tip Bipolar Forceps | ACBF-012 | FDA UDI | Class II | Active |
| Surgitron 4.0 Dual Rf/90 | IEC3A-S30-90/110-USA | FDA UDI | Class II | Active |
| Laser System, Vectus, Brazil | 105-3500-100 | FDA UDI | Class II | Active |
| Assy, Mask Flex Circuit, Med, Sub | 100-7026-816 | FDA UDI | Class II | Active |
| PELLEFIRM Handpiece | P330PFHPU | FDA UDI | Class II | Active |
| EMPIRE microIncision Needle Electrodes | TEE312 | FDA UDI | Class II | Active |
| Frigi-Dent | EFD140A | FDA UDI | Class II | Active |
| Pelleve GlideSafe 20MM HP, 1PC | P220HPD1 | FDA UDI | Class II | Active |
| Handpiece tip, reusable | 100-7009-086 | FDA UDI | Class II | Active |
| Max Ys Handpiece | 2520B-YS06R | FDA UDI | Class II | Active |
| YABE Electrode | EE239 | FDA UDI | Class II | Active |
| Nubond Post | EPO1673 | FDA UDI | Class I | Active |
| Pv Glidesafe Hp & Cable 10mm Intl (3 Hp) | P210HPD | FDA UDI | Class II | Active |
| ASSY, Smart Sense Handpiece, Lipo Molded, 1040 OD | 100-7007-740 | FDA UDI | Class II | Active |
| Coated Antenna Plate | H4 | FDA UDI | Class II | Active |
| FlexSure Large Applicator 10-Pack | ASY-14112 | FDA UDI | Class II | Active |
| ASSY, Probe Kit, 5 PK, TempSure Vitalia | 100-7037-100 | FDA UDI | Class II | Active |
| PelleFirm 25MM HP, 3-pack | P325PFHPU | FDA UDI | Class II | Active |
| Press Form Kit | EPF172A | FDA UDI | Class I | Active |
| Bipolar Cable | IEC-BIUC | FDA UDI | Class II | Active |
| Monoploar Cable | IEC-UC | FDA UDI | Class II | Active |
| Pelleve Quick Connect Cable | P2CBP | FDA UDI | Class II | Active |
| Bipolar Cable | JX/E | FDA UDI | Class II | Active |
| 25mm Portrait Handpiece | 100-7027-125 | FDA UDI | Class II | Active |
| Smartlipo Fiber w/ RFID, 600um Fiber, 10 pack | 807-5001-614 | FDA UDI | Class II | Active |
| Press Form Sheets | EPS352 | FDA UDI | Class I | Active |
| Suction Coagulator Kit | H40 | FDA UDI | Class II | Active |
| Needles-Bulkpak | H1375 | FDA UDI | Class II | Active |
| Suction Handle For Corneal Shields | H78A | FDA UDI | Class I | Active |
| SideLaze800 Fiber w/RFID, 800um, 10 pack | 807-5001-618 | FDA UDI | Class II | Active |
| 2940 handpiece | 2520A-2940 | FDA UDI | Class II | Active |
| FlexSure Interface Adapter | ASY-14116 | FDA UDI | Class II | Active |
| Upgrade, Final TempSure System, Aesth&Surgical | U100-7027-510 | 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 |