GentleMax Pro Plus
Powered Laser Surgical Instrument
Candela Corporation
The following data is part of a premarket notification filed by Candela Corporation with the FDA for Gentlemax Pro Plus.
Pre-market Notification Details
| Device ID | K201111 |
| 510k Number | K201111 |
| Device Name: | GentleMax Pro Plus |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Candela Corporation 251 Locke Dr Marlborough, MA 01752 |
| Contact | Yverre Bobay |
| Correspondent | Yverre Bobay Candela Corporation 251 Locke Dr Marlborough, MA 01752 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-27 |
| Decision Date | 2020-05-26 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817495023243 | K201111 | 000 |
| 00817495023052 | K201111 | 000 |
| 00817495023045 | K201111 | 000 |
| 00817495023038 | K201111 | 000 |
| 00817495023021 | K201111 | 000 |
| 00817495022994 | K201111 | 000 |
| 00817495022970 | K201111 | 000 |
| 00817495024110 | K201111 | 000 |
| 00817495024080 | K201111 | 000 |
| 00817495024127 | K201111 | 000 |
| 00817495025186 | K201111 | 000 |
| 00817495025155 | K201111 | 000 |
| 00817495024257 | K201111 | 000 |
| 00817495025049 | K201111 | 000 |
| 00817495025032 | K201111 | 000 |
| 00817495023915 | K201111 | 000 |
| 00817495023069 | K201111 | 000 |
| 00817495023076 | K201111 | 000 |
| 00817495023083 | K201111 | 000 |
| 00817495023236 | K201111 | 000 |
| 00817495023229 | K201111 | 000 |
| 00817495023212 | K201111 | 000 |
| 00817495023205 | K201111 | 000 |
| 00817495023199 | K201111 | 000 |
| 00817495023182 | K201111 | 000 |
| 00817495023175 | K201111 | 000 |
| 00817495023168 | K201111 | 000 |
| 00817495023151 | K201111 | 000 |
| 00817495023144 | K201111 | 000 |
| 00817495023137 | K201111 | 000 |
| 00817495023120 | K201111 | 000 |
| 00817495022987 | K201111 | 000 |
| 00817495023519 | K201111 | 000 |
| 00817495023502 | K201111 | 000 |
| 00817495023854 | K201111 | 000 |
Trademark Results [GentleMax Pro Plus]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GENTLEMAX PRO PLUS 90168154 not registered Live/Pending |
Candela Corporation 2020-09-09 |
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