The following data is part of a premarket notification filed by Lois Yee Cosmetics, Inc. with the FDA for Epilator 8500.
| Device ID | K851413 |
| 510k Number | K851413 |
| Device Name: | EPILATOR 8500 |
| Classification | Epilator, High Frequency, Tweezer-type |
| Applicant | LOIS YEE COSMETICS, INC. 1850 SOUTH ELDORADO ST. P.O. BOX 6188 Stockton, CA 95206 |
| Contact | K Yee |
| Correspondent | K Yee LOIS YEE COSMETICS, INC. 1850 SOUTH ELDORADO ST. P.O. BOX 6188 Stockton, CA 95206 |
| Product Code | KCX |
| CFR Regulation Number | 878.5360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-09 |
| Decision Date | 1985-06-10 |