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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 8 of 15| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Cynosure Photolight Flashlamp System | K974674 | FDA 510(k) | Class II | Active |
| Elite + Laser System | K141425 | FDA 510(k) | Class II | Active |
| Cynosure Phototripter Laser | K921840 | FDA 510(k) | Class II | Active |
| Cynosure Photogenica Neo-V | K004039 | FDA 510(k) | Class II | Active |
| Cynosure Photogenica 532 Laser | K974900 | FDA 510(k) | Class II | Active |
| Picosure Workstation | K121346 | FDA 510(k) | Class II | Active |
| Cynosure Apogee-Tks Dermatological Laser | K992757 | FDA 510(k) | Class II | Active |
| Affinity Qs Q-Switched Nd:yag Laser System | K050382 | FDA 510(k) | Class II | Active |
| Cynosure Phototome Surgical Diode Laser | K935305 | FDA 510(k) | Class II | Active |
| Asa 'm Family' Diode Laser, Model Mi, Mix5, M6 | K051922 | FDA 510(k) | Class II | Active |
| Hilt Family Laser: Hilt I, Hilt Ii, Hilt Iii | K051537 | FDA 510(k) | Class II | Active |
| Cellulaze Laser | K123407 | FDA 510(k) | Class II | Active |
| Cynosure Yag Family Laser | K072484 | FDA 510(k) | Class II | Active |
| Cynosure Photogenica Lp Dermatological Vascular Lesion Laser | K963094 | FDA 510(k) | Class II | Active |
| Picosure Workstation | K143105 | FDA 510(k) | Class II | Active |
| SculpSure | K182741 | FDA 510(k) | Class II | Active |
| Cynosure Photogenica Vl Cutaneous Vascular Lesion Laser | K960579 | FDA 510(k) | Class II | Active |
| Revlite Q-Switched Nd:yag Laser System | K133254 | FDA 510(k) | Class II | Active |
| Smartxide | K031224 | FDA 510(k) | Class II | Active |
| Cynosure Smartlipo Multiwavlength Laser | K080121 | FDA 510(k) | Class II | Active |
| Cynosure Smartlipo Multiwavelength Laser With 1440nm Wavelength | K091537 | FDA 510(k) | Class II | Active |
| Cynosure Smart File Nd:yag Lasers | K031125 | FDA 510(k) | Class II | Active |
| Cynosure Photolight Pl | K031258 | FDA 510(k) | Class II | Active |
| Cynosure Accolade Laser | K992814 | FDA 510(k) | Class II | Active |
| Iluminage Skin Smoothing Laser | K133473 | FDA 510(k) | Class II | Active |
| Cynosure Photogenica Vl | K032565 | FDA 510(k) | Class II | Active |
| PicoSure Workstation | K173199 | FDA 510(k) | Class II | Active |
| Cynosure Apogee-Tks Ii Dermatological Laser | K031488 | FDA 510(k) | Class II | Active |
| Cynergy Laser | K043429 | FDA 510(k) | Class II | Active |
| Cynosure Surescan With The Co3 Er: Yag Laser | K992084 | FDA 510(k) | Class II | Active |
| Cynosure Photogenica T10 Tattoo Removal Laser | K950684 | FDA 510(k) | Class II | Active |
| Apogee Elite | K034030 | FDA 510(k) | Class II | Active |
| Cynosure Smart 2940d Er:yag Laser | K031389 | FDA 510(k) | Class II | Active |
| Photosilk Pulsed Light System | K041095 | FDA 510(k) | Class II | Active |
| Smart 2940 D Er: Yag Laser | K031317 | FDA 510(k) | Class II | Active |
| SculpSure | K171992 | FDA 510(k) | Class II | Active |
| Elite iQ | K193426 | FDA 510(k) | Class II | Active |
| Picosure Workstation | K133364 | FDA 510(k) | Class II | Active |
| Elite Mpx Laser System With Cryo C | K091169 | FDA 510(k) | Class II | Active |
| Cynosure Smartlipo Mpx Laser With Smartsense C Module | K083379 | FDA 510(k) | Class II | Active |
| Cynosure Photogenica Dl | K010005 | FDA 510(k) | Class II | Active |
| MyEllevate | K230510 | FDA 510(k) | Class II | Active |
| Smartepil | K020107 | FDA 510(k) | Class II | Active |
| Cynosure Cellulaze Laser | K102541 | FDA 510(k) | Class II | Active |
| Affirm Do Diode Laser | K101601 | FDA 510(k) | Class II | Active |
| Cynosure 1064nm Diode Laser | K123971 | FDA 510(k) | Class II | Active |
| Elite Mpx Laser System With Xpl Handpiece | K090235 | FDA 510(k) | Class II | Active |
| Sidelaze Laser Beam Delivery Accessory For Cynosure 1440nm Wavelength Lasers | K121127 | FDA 510(k) | Class II | Active |
| Affirm With Xpl Handpiece And Er:yag Laser Module | K080006 | FDA 510(k) | Class II | Active |
| Accolade Ii Laser | K072868 | 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 |