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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 1 of 15| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| MaxG 4mm Adapter | 2520-0027 | FDA UDI | Class II | Active |
| ASSY, 25MM Massage Head, TempSure | 100-7027-055 | FDA UDI | Class II | Active |
| 10mm Portrait Handpiece | 100-7027-110 | FDA UDI | Class II | Active |
| Ace-Tip Bipolar Forceps | ACBF-016 | FDA UDI | Class II | Active |
| PrecistionTx Handpiece, 2 Pack | 100-7019-015 | FDA UDI | Class II | Active |
| Dento-Surg | DEN90110 | FDA UDI | Class II | Active |
| Max Ys Handpiece | 2520B-YS06 | FDA UDI | Class II | Active |
| Raup Electrode | H81A1 | FDA UDI | Class II | Active |
| YABE Electrode | IEC-EE239 | FDA UDI | Class II | Active |
| LUXY HP, StarLux Repl. | 1520-Y026R | FDA UDI | Class II | Active |
| EMPIRE microIncision Needle Electrodes | TEE303 | FDA UDI | Class II | Active |
| 15mm Portrait Handpiece | 100-7027-115 | FDA UDI | Class II | Active |
| 10mm GlideSafe HP (3) and Cable | P210HPD | FDA UDI | Class II | Active |
| MaxG HP, Starlux 500 | 5520A-G046 | FDA UDI | Class II | Active |
| MaxY Handpiece | 2520B-Y026 | FDA UDI | Class II | Active |
| Acusect | ACS-S50/110 | FDA UDI | Class II | Active |
| Press Form Sheets | EPS1776 | FDA UDI | Class I | Active |
| SlimlipoTip 175 mm, EO | 0320-0031 | FDA UDI | Class II | Active |
| Focal Guide 10 x 10 | 5520-2024 | FDA UDI | Class II | Active |
| SculpSure Applicator | 100-7026-100 | FDA UDI | Class II | Active |
| Spacer tip, handpiece | 130-7012-324 | FDA UDI | Class II | Active |
| EMPIRE microIncision Needle Electrodes | TEE326 | FDA UDI | Class II | Active |
| Emerge | 0500-0001R | FDA UDI | Class II | Active |
| Slimlipo, 275mm Tip, EO | 0320-0032 | FDA UDI | Class II | Active |
| Pelleve GlideSafe 7.5MM HP, 1PC | P275HPD1 | FDA UDI | Class II | Active |
| Rf Suction Adenoid Set | IEC-H85 | FDA UDI | Class II | Active |
| MaxYs 4mm Adapter | 2520-0045 | FDA UDI | Class II | Active |
| 1064+ Handpiece | 2520A-1064P | FDA UDI | Class II | Active |
| Press form Sheets, Hard, 0.040 | EPS1774 | FDA UDI | Class I | Active |
| Slimlipo Tip, 100mm Length, EO | 0320-0029 | FDA UDI | Class II | Active |
| EMPIRE microIncision Needle Electrodes | TEE318 | FDA UDI | Class II | Active |
| 650nm Revlite SI Dye Handpiece, Red | 100-7017-063 | FDA UDI | Class II | Active |
| Max Rs Handpiece | 2520B-RS26R | FDA UDI | Class II | Active |
| Ellman-Cot | H97 | FDA UDI | Class I | Active |
| 532 Lite Handpiece | 659-0644 | FDA UDI | Class II | Active |
| PelleFirm 30MM Handpiece, 1 PC | P330PFHP1 | FDA UDI | Class II | Active |
| Speculum | H57 | FDA UDI | Class I | Active |
| Reamer | EPO1661 | FDA UDI | Class I | Active |
| GlideSafe Handpiece Cord | 30-0361 | FDA UDI | Class II | Active |
| MAXG HP, StarLux 500 Refurb | 5520A-G046R | FDA UDI | Class II | Active |
| Suction Coagulator Tube | H46 | FDA UDI | Class II | Active |
| Chedly Eyelid Retractor | H21A | FDA UDI | Class I | Active |
| Metal Cone, one piece | 659-1154 | FDA UDI | Class II | Active |
| Emerge Handpiece | 0520A-0001R | FDA UDI | Class II | Active |
| AcuSect | ACS-S50/220-ANZ | FDA UDI | Class II | Active |
| Extra-Large Grounding Pad | MEL-01197 | FDA UDI | Class II | Active |
| 2941 handpiece | 2520A-2940R | FDA UDI | Class II | Active |
| 60mm Handpiece W/Acc, Tempsure | 100-7027-165 | FDA UDI | Class II | Active |
| Max R Handpiece | 2520B-R026 | FDA UDI | Class II | Active |
| Self-Span | ESS144 | FDA UDI | Class I | 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 |