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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 9 of 15| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Cynosure Photogenica Sv Laser | K032539 | FDA 510(k) | Class II | Active |
| Cynosure Smartlipo Mpx Laser | K083795 | FDA 510(k) | Class II | Active |
| Cynosure Dioderm | K992765 | FDA 510(k) | Class II | Active |
| Cynosure Photogenica Vl | K012806 | FDA 510(k) | Class II | Active |
| Yag Mir Ii Laser | K070063 | FDA 510(k) | Class II | Active |
| Cynosure Photogenica Er | K012790 | FDA 510(k) | Class II | Active |
| Smart Co2 (smart Us 20d, Smart Clinic) Surgical Laser | K031440 | FDA 510(k) | Class II | Active |
| Cynosure Photogenica Sv | K021444 | FDA 510(k) | Class II | Active |
| Cynosure Photodent, Intraoral Surgical Laser | K921843 | FDA 510(k) | Class II | Active |
| Smartlipo Nd:yag Laser | K062321 | FDA 510(k) | Class II | Active |
| Cynosure Photogenica Spir | K994437 | FDA 510(k) | Class II | Active |
| Smart Co2 (smart Us 20d / Ultraspeed, Smart Clinic And Periopulse) Surgical Laser | K081181 | FDA 510(k) | Class II | Active |
| Cynosure Erasure Laser | K984517 | FDA 510(k) | Class II | Active |
| Cynosure Photgenica V Cutaneous Vas. Lesion Laser | K921842 | FDA 510(k) | Class II | Active |
| Cynosure Dls-10-810 Diode Laser General Photocoagulator | K970243 | FDA 510(k) | Class II | Active |
| Cynosure Acclaim Dermatology Laser | K011828 | FDA 510(k) | Class II | Active |
| Tristar Aesthetic Workstation Laser | K033176 | FDA 510(k) | Class II | Active |
| Cynosure Dermatology Laser Cooling Tip | K972002 | FDA 510(k) | Class II | Active |
| Cynosure Photoappeal Co2 Surgical Lasers | K962993 | FDA 510(k) | Class II | Active |
| Cynosure Photogenica P Pigmented Lesion Laser | K921841 | FDA 510(k) | Class II | Active |
| Yag Mir Family Laser | K053421 | FDA 510(k) | Class II | Active |
| Sidelaze800 Laser Beam Delivery Accessory For Cynosure 1440mm Wavelength Lasers | K141511 | FDA 510(k) | Class II | Active |
| Cynosure Smartcool Family Cold Air Device: Smartcool, Smartcool 6 And Cryo C | K090618 | FDA 510(k) | Class II | Active |
| Cynosurea Eclilite And Eclilite U | K050080 | FDA 510(k) | Class II | Active |
| Round Loop Electrode | TBB/REG | EUDAMEDFDA UDI | Class IIb | Active |
| Ellman Microtip Needles | TEE227 | EUDAMEDFDA UDI | Class IIb | Active |
| Round Loop Electrode | QTB1B | EUDAMEDFDA UDI | Class IIb | Active |
| Ace-Tip Electrode | TNAB4B | EUDAMEDFDA UDI | Class IIb | Active |
| Ent Electrode | S13B | EUDAMEDFDA UDI | Class IIb | Active |
| Triangle Electrode | TC10B/4 | EUDAMEDFDA UDI | Class IIb | Active |
| INSULATED Sclerotherapy | D43 | EUDAMEDFDA UDI | Class IIb | Active |
| Triangle Loop Electrode | XTFB/4 | EUDAMEDFDA UDI | Class IIb | Active |
| 113f Electrode | T113FB | EUDAMEDFDA UDI | Class IIb | Active |
| 3-BUTTON FingerSwitch BLADE Handpiece | IEC-XBHP3 | EUDAMEDFDA UDI | Class IIb | Active |
| Ophthalmic Micro-Dissection | TA10/C3 | EUDAMEDFDA UDI | Class IIb | Active |
| U-Shape Electrode | 108D | EUDAMEDFDA UDI | Class IIb | Active |
| Lletz Electrode | XW1 | EUDAMEDFDA UDI | Class IIb | Active |
| Bipolar Forceps | J1B | EUDAMEDFDA UDI | Class IIb | Active |
| Round Loop Electrode | TB2B | EUDAMEDFDA UDI | Class IIb | Active |
| Oval Loop Electrode | TP8B | EUDAMEDFDA UDI | Class IIb | Active |
| Ball Electrode | TD11B | EUDAMEDFDA UDI | Class IIb | Active |
| Diamond Loop Electrode | TC17B/4 | EUDAMEDFDA UDI | Class IIb | Active |
| Ace-Tip Electrode | TNAEE285 | EUDAMEDFDA UDI | Class IIb | Active |
| Diamond Electrode | TC18B/4 | EUDAMEDFDA UDI | Class IIb | Active |
| TempSure-RF System | 100-7027-010 | EUDAMEDFDA UDI | Class IIb | Active |
| Ball Electrode | TD11B/4 | EUDAMEDFDA UDI | Class IIb | Active |
| Insulated Needle | D6B | EUDAMEDFDA UDI | Class IIb | Active |
| Diamond Loop Electrode | TC1B | EUDAMEDFDA UDI | Class IIb | Active |
| Lletz Electrode | F2 | EUDAMEDFDA UDI | Class IIb | Active |
| Accolade | 100-7008-010 | EUDAMEDFDA UDI | Class IIb | 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 |