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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 2 of 15| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Focus Cap Array | 100-7012-055 | FDA UDI | Class II | Active |
| YABE MYRINGOTOMY Electrodes | QEE238 | FDA UDI | Class II | Active |
| Pelleve S5 | IEC5P-ST/110-USA (MOD2) | FDA UDI | Class II | Active |
| PELLEFIRM Handpiece | P325PFHPU | FDA UDI | Class II | Active |
| Rfb, Assy, Final Tempsure System | R100-7027-010 | FDA UDI | Class II | Active |
| Speculum | H55 | FDA UDI | Class I | Active |
| Elite+ / Elite MPX Treatment Tip | 100-7018-100 | FDA UDI | Class II | Active |
| PelleFirm 25MM Handpiece, 1 PC | P325PFHP1 | FDA UDI | Class II | Active |
| MultiLite Dye Handpiece Kir | 100-7017-067 | FDA UDI | Class I | Active |
| Neutral Pad | IEC-NPD1 | FDA UDI | Class II | Active |
| ASSY, Handpiece Kit, TempSure Vitalia | 100-7037-200 | FDA UDI | Class II | Active |
| Ace-Tip Electrode | TNAD13B | FDA UDI | Class II | Active |
| Focal Guide 6 x 6 | 5520-2027 | FDA UDI | Class II | Active |
| Scalpel Electrodes | E5D/9 | FDA UDI | Class II | Active |
| Surgitron 4.0 Dual Rf S5 | IEC5-S30/110-USA | FDA UDI | Class II | Active |
| Scalpel Electrodes | E5D | FDA UDI | Class II | Active |
| Surg-E-Vac Smoke Evacuation System | SVD110 | FDA UDI | Class II | Active |
| Frigi-Dent | EFD140ACS | FDA UDI | Class II | Active |
| ASSY, Handpiece, 60mm, TempSure | ASY-12745 | FDA UDI | Class II | Active |
| Corneal Shield | H76A | FDA UDI | Class I | Active |
| Rfb, Assy, Final Laser, Sculpsure, Sub Only | R100-7026-910 | FDA UDI | Class II | Active |
| Press Form Sheets, 0.20, 100 PCS | EPS1762 | FDA UDI | Class I | Active |
| 7.5mm GlideSafe HP (3) and Cable | P275HPD | FDA UDI | Class II | Active |
| PELLEFIRM Handpiece | P3PFVP-WMHU | FDA UDI | Class II | Active |
| Assy, Focus Array, Platinum, Picosure | 100-7012-057 | FDA UDI | Class II | Active |
| 2940 HP, Artisan, RFB | 8520A-2940R | FDA UDI | Class II | Active |
| Glass Fibre Post | EGF202 | FDA UDI | Class I | Active |
| 1064+ Handpiece | 2520A-1064PR | FDA UDI | Class II | Active |
| Glass Fibre Post | EGF201 | FDA UDI | Class I | Active |
| Max Rs Handpiece | 2520B-RS26 | FDA UDI | Class II | Active |
| Ace-Tip Bipolar Forceps | ACBF-022 | FDA UDI | Class II | Active |
| Medi-Frig | H11B | FDA UDI | Class II | Active |
| Ace-Tip Bipolar Forceps | ACBF-011 | FDA UDI | Class II | Active |
| Pelleve S5 | IEC5P-ST (MOD2) | FDA UDI | Class II | Active |
| Skintel Melanin Reader | 2520B-0038R | FDA UDI | Class II | Active |
| FlexSure Medium Applicator | ASY-14115 | FDA UDI | Class II | Active |
| Vectus - Base Module Reman | 3520-0009R | FDA UDI | Class II | Active |
| Roto-Pro Rotosonic | ERP104 | FDA UDI | Class I | Active |
| SI Dye Handpiece Kit | 100-7017-068 | FDA UDI | Class II | Active |
| Quick Connect Cable | SP020 | FDA UDI | Class II | Active |
| PicoSure 532 nm Handpiece | 100-7012-076 | FDA UDI | Class II | Active |
| 2940 HP, Artisan | 8520A-2940 | FDA UDI | Class II | Active |
| Pelleve GlideSafe 15MM HP, 1PC | P215HPD1 | FDA UDI | Class II | Active |
| Suction Coagulator Kit | IEC-H40 | FDA UDI | Class II | Active |
| DR. Beigi's Electrodes | TEE603 | FDA UDI | Class II | Active |
| Blade Handpiece | H15 | FDA UDI | Class II | Active |
| MaxY Handpiece, Remanufactured | 2520B-Y026R | FDA UDI | Class II | Active |
| Emerge Handpiece | 0520A-0001 | FDA UDI | Class II | Active |
| F.f.p.f. Emc | EMC110A | FDA UDI | Class II | Active |
| Ace-Tip Bipolar Forceps | ACBF-017 | 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 |