Accure Laser
Powered Laser Surgical Instrument
Accure Acne, Inc.
The following data is part of a premarket notification filed by Accure Acne, Inc. with the FDA for Accure Laser.
Pre-market Notification Details
| Device ID | K222109 |
| 510k Number | K222109 |
| Device Name: | Accure Laser |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Accure Acne, Inc. 4699 Nautilus Ct. South, Suite 205 Boulder, CO 80301 -5307 |
| Contact | Karl Nicholls |
| Correspondent | Kevin Walls FDA Compliance Group 33 Golden Eagle Lane Littleton, CO 80127 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-07-18 |
| Decision Date | 2022-11-17 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08059173392230 | K222109 | 000 |
Trademark Results [Accure Laser]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACCURE LASER 88908551 not registered Live/Pending |
Accure Acne, Inc 2020-05-09 |
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