Elite IQ
Powered Laser Surgical Instrument
Cynosure LLC
The following data is part of a premarket notification filed by Cynosure Llc with the FDA for Elite Iq.
Pre-market Notification Details
| Device ID | K193426 |
| 510k Number | K193426 |
| Device Name: | Elite IQ |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Cynosure LLC 5 Carlisle Road Westford, MA 01886 |
| Contact | Michael King |
| Correspondent | Michael King Cynosure LLC 5 Carlisle Road Westford, MA 01886 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-10 |
| Decision Date | 2020-03-09 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08057017760467 | K193426 | 000 |
| 08057017760450 | K193426 | 000 |
Trademark Results [Elite IQ]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ELITE IQ 88665680 not registered Live/Pending |
Cynosure, LLC 2019-10-23 |
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