The following data is part of a premarket notification filed by Johnson & Johnson Consumer Inc. with the FDA for Neutrogena Light Therapy Acne Mask+.
| Device ID | K180847 |
| 510k Number | K180847 |
| Device Name: | Neutrogena Light Therapy Acne Mask+ |
| Classification | Over-the-counter Powered Light Based Laser For Acne |
| Applicant | Johnson & Johnson Consumer Inc. 7050 Camp Hill Rd Fort Washington, PA 19034 |
| Contact | Timothy Kline |
| Correspondent | Timothy Kline Johnson & Johnson Consumer Inc. 7050 Camp Hill Rd Fort Washington, PA 19034 |
| Product Code | OLP |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-02 |
| Decision Date | 2018-06-19 |
| Summary: | summary |