Profound Matrix
Electrosurgical, Cutting & Coagulation & Accessories
Candela Corporation
The following data is part of a premarket notification filed by Candela Corporation with the FDA for Profound Matrix.
Pre-market Notification Details
| Device ID | K211217 |
| 510k Number | K211217 |
| Device Name: | Profound Matrix |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Candela Corporation 251 Locke Dr Marlborough, MA 01752 |
| Contact | Jeffrey Churchill |
| Correspondent | Rina Ordonez Candela Corporation 251 Locke Dr Marlborough, MA 01752 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-23 |
| Decision Date | 2021-12-16 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817495023311 | K211217 | 000 |
| 07290109952949 | K211217 | 000 |
| 00817495023755 | K211217 | 000 |
| 00817495023748 | K211217 | 000 |
| 00817495023731 | K211217 | 000 |
| 00817495023724 | K211217 | 000 |
| 00817495023717 | K211217 | 000 |
| 00817495024073 | K211217 | 000 |
| 00817495021379 | K211217 | 000 |
| 00817495020310 | K211217 | 000 |
| 07290109952956 | K211217 | 000 |
| 07290109952970 | K211217 | 000 |
| 07290109952987 | K211217 | 000 |
| 00817495023793 | K211217 | 000 |
| 00817495023786 | K211217 | 000 |
| 00817495023779 | K211217 | 000 |
| 00817495023762 | K211217 | 000 |
| 00817495023830 | K211217 | 000 |
| 00817495023823 | K211217 | 000 |
| 00817495023816 | K211217 | 000 |
| 00817495023809 | K211217 | 000 |
| 47290109952961 | K211217 | 000 |
| 00817495020303 | K211217 | 000 |
Trademark Results [Profound Matrix]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PROFOUND MATRIX 97024431 not registered Live/Pending |
Candela Corporation 2021-09-13 |
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