The following data is part of a premarket notification filed by Carol Block, Ltd. with the FDA for D'plume Xxii Photocoagulator (epilation Machine).
| Device ID | K895687 |
| 510k Number | K895687 |
| Device Name: | D'PLUME XXII PHOTOCOAGULATOR (EPILATION MACHINE) |
| Classification | Epilator, High Frequency, Needle-type |
| Applicant | CAROL BLOCK, LTD. 7701 BULL VALLEY RD. Mc Henry, IL 60050 |
| Contact | Carol Block |
| Correspondent | Carol Block CAROL BLOCK, LTD. 7701 BULL VALLEY RD. Mc Henry, IL 60050 |
| Product Code | KCW |
| CFR Regulation Number | 878.5350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-22 |
| Decision Date | 1990-08-09 |