The following data is part of a premarket notification filed by Foreo Inc. with the FDA for Espada Acne-clearing Blue Light Pen.
| Device ID | K162450 |
| 510k Number | K162450 |
| Device Name: | ESPADA Acne-Clearing Blue Light Pen |
| Classification | Over-the-counter Powered Light Based Laser For Acne |
| Applicant | FOREO INC. 1525 Pama Lane, Suite 200 Las Vegas, NV 89119 |
| Contact | Davor Soldo |
| Correspondent | Kevin Walls Regulatory Insight, Inc. 33 Golden Eagle Lane Littleton, CO 80127 |
| Product Code | OLP |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-01 |
| Decision Date | 2016-11-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07350092130288 | K162450 | 000 |
| 07350092130271 | K162450 | 000 |
| 07350092130011 | K162450 | 000 |
| 07350120791764 | K162450 | 000 |
| 07350120791757 | K162450 | 000 |
| 07350120791771 | K162450 | 000 |
| 07350120790538 | K162450 | 000 |
| 07350120790521 | K162450 | 000 |