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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 7 of 15| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Bipolar Forceps | J9 | EUDAMEDFDA UDI | Class IIb | Active |
| EMPIRE microIncision Needle Electrode | TEE328 | EUDAMEDFDA UDI | Class IIb | Active |
| Needle Electrode | TA3B | EUDAMEDFDA UDI | Class IIb | Active |
| Ball Electrode | TD8B | EUDAMEDFDA UDI | Class IIb | Active |
| Ace-Tip Electrode Set | NAS10B | EUDAMEDFDA UDI | Class IIb | Active |
| OVAL Loop ELECTRODE | TP5B/4 | EUDAMEDFDA UDI | Class IIb | Active |
| Lletz Bayonet | W33 | EUDAMEDFDA UDI | Class IIb | Active |
| Assorted Ball Electrode | XDB/4 | EUDAMEDFDA UDI | Class IIb | Active |
| Triangle Loop Electrode | TC8B | EUDAMEDFDA UDI | Class IIb | Active |
| Bipolar Forceps | J12 | EUDAMEDFDA UDI | Class IIb | Active |
| Round Loop Electrode | TBBB/4 | EUDAMEDFDA UDI | Class IIb | Active |
| 3 Button FSHP | IEC-3FHPB/D1 | EUDAMEDFDA UDI | Class IIb | Active |
| Round Loop Electrode | TBBB | EUDAMEDFDA UDI | Class IIb | Active |
| Conization Electrode | G1/4 | EUDAMEDFDA UDI | Class IIb | Active |
| Ace Tip Electrode | TREE305 | EUDAMEDFDA UDI | Class IIb | Active |
| Cryptolysis Electrode | TE1022B | EUDAMEDFDA UDI | Class IIb | Active |
| EMPIRE microIncision Needle Electrodes | QTEE309 | EUDAMEDFDA UDI | Class IIb | Active |
| Icon | 105-2500-000 | EUDAMEDFDA UDI | Class IIb | Active |
| Oval Loop Electrode | TP9B | EUDAMEDFDA UDI | Class IIb | Active |
| Round Loop | B2D | EUDAMEDFDA UDI | Class IIb | Active |
| 127 Electrode | T127B | EUDAMEDFDA UDI | Class IIb | Active |
| Troughing Electrode | 113FD | EUDAMEDFDA UDI | Class IIb | Active |
| Cynosure Yag Family Laser (photogenica Yag And Acclaim) | K031690 | FDA 510(k) | Class II | Active |
| Cynosure Photogenica Er Laser | K973498 | FDA 510(k) | Class II | Active |
| Cynosure M2 Dermatology Laser For Hair Removal | K994427 | FDA 510(k) | Class II | Active |
| Affirm Co2 And Affirm Co2 Hp | K081424 | FDA 510(k) | Class II | Active |
| Cynosure Photogenica Vls-Star | K000490 | FDA 510(k) | Class II | Active |
| Smartlite D Frequency Doubled Nd:yag Laser | K040289 | FDA 510(k) | Class II | Active |
| Smartlipo Laser | K073394 | FDA 510(k) | Class II | Active |
| Asa 'mphi Family Diode Laser | K111901 | FDA 510(k) | Class II | Active |
| Iluminage Diode Laser | K111454 | FDA 510(k) | Class II | Active |
| Palomar Icon Aesthetic System | K142376 | FDA 510(k) | Class II | Active |
| Sculpsure | K171111 | FDA 510(k) | Class II | Active |
| SculpSure | K160470 | FDA 510(k) | Class II | Active |
| SculpSure | K150230 | FDA 510(k) | Class II | Active |
| Cynosure Photogenica Lpir Dermatological Laser | K971737 | FDA 510(k) | Class II | Active |
| Elite iQ PRO (M122K1) | K240396 | FDA 510(k) | Class II | Active |
| PicoSure Workstation | K160480 | FDA 510(k) | Class II | Active |
| Cynosure Photogenica T Tattoo Removal Laser | K923683 | FDA 510(k) | Class II | Active |
| Cynergy Multiplex Laser | K050779 | FDA 510(k) | Class II | Active |
| Cynosure Co3 Er:yag Laser | K983034 | FDA 510(k) | Class II | Active |
| Photosilk Plus Pulsed Light System And Laser Attachment | K051442 | FDA 510(k) | Class II | Active |
| TempSure | K190678 | FDA 510(k) | Class II | Active |
| Cynosure Photogenica Vlv Cutaneous Vascular Lesion Laser | K965128 | FDA 510(k) | Class II | Active |
| Cynosure Triactive Therapeutic Massage System | K030876 | FDA 510(k) | Class I | Active |
| Picosure Workstation | K140719 | FDA 510(k) | Class II | Active |
| TempSure | K171262 | FDA 510(k) | Class II | Active |
| Cynosure Photogenica V-Star Laser | K053608 | FDA 510(k) | Class II | Active |
| SculpSure | K150724 | FDA 510(k) | Class II | Active |
| PicoSure Workstation | K210226 | FDA 510(k) | 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 |