Medical device manufacturer
Cynosure, Inc.
Cynosure, Inc. holds 108 FDA 510(k) clearances across 10 product codes. Median elapsed review time is 88 days. openFDA lists 1 recall record naming the company. FDA publishes it under 7 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 108
- Product codes
- 10
- Median review
- 88 days
- Recall records
- 1
How does FDA spell Cynosure, Inc.?
FDA publishes this company under 7 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| CYNOSURE, LLC | device/registrationlisting | normalised |
| Cynosure | device/510k | normalised |
| Cynosure, Inc. | device/510k | normalised |
| Cynosure, Inc. | device/enforcement | normalised |
| Cynosure, Inc. | device/recall | normalised |
| Cynosure, Inc. Dba Ellman | device/510k | normalised |
| Cynosure, LLC | device/510k | normalised |
Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does Cynosure, Inc. file in?
10 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 85 | 84 days | |
| PKT | Laser For Disruption Of Adipocyte Cells For Aesthetic Use | 6 | 97 days | |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 5 | 128 days | |
| ILY | Lamp, Infrared, Therapeutic Heating | 4 | 108 days | |
| OHS | Light Based Over The Counter Wrinkle Reduction | 2 | 64 days | |
| OYW | Laser, Cellulite Appearance | 2 | 144 days | |
| FTC | Light, Ultraviolet, Dermatological | 1 | 112 days | |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 1 | 132 days | |
| ISA | Massager, Therapeutic, Electric | 1 | 308 days | |
| PBX | Massager, Vacuum, Radio Frequency Induced Heat | 1 | 54 days |
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Cynosure, Inc. had a recall?
openFDA lists 1 recall record naming this company across its whole history. A recall record covers one firm's corrective action and may span many device lots.
Z-0169-2015Class IITerminatedGEX
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
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Cynosure, Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K261570 | PICOSURE WORKSTATION | GEX | 36 | |
| K240396 | Elite iQ PRO (M122K1) | GEX | 29 | |
| K230510 | MyEllevate | GAT | 132 | |
| K223292 | TempSure System | GEI | 28 | |
| K212891 | TempSure System | GEI | 189 | |
| K210226 | PicoSure Workstation | GEX | 61 | |
| K200241 | TempSure System | PBX | 54 | |
| K193426 | Elite iQ | GEX | 90 | |
| K190678 | TempSure | GEI | 128 | |
| K182741 | SculpSure | PKT | 97 |
Source: openFDA device/510k · retrieved
Where is Cynosure, Inc. registered?
FDA lists 1 registered establishment for this company in US.
Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.
Watch what Cynosure, Inc. files next
Get an email when this company clears a new device, or when anything is recalled in a product code you follow.
Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.