The following data is part of a premarket notification filed by Pacific Poly Crafts with the FDA for Laser Skin Marker And Mask White Lotion.
| Device ID | K861772 |
| 510k Number | K861772 |
| Device Name: | LASER SKIN MARKER AND MASK WHITE LOTION |
| Classification | Marker, Skin |
| Applicant | PACIFIC POLY CRAFTS 205 NORTH GARDEN ST. VENTURA, CA 93001 -2532 |
| Contact | JANET R SEREGELY |
| Correspondent | JANET R SEREGELY PACIFIC POLY CRAFTS 205 NORTH GARDEN ST. VENTURA, CA 93001 -2532 |
| Product Code | FZZ |
| CFR Regulation Number | 878.4660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-07 |
| Decision Date | 1986-05-21 |