The following data is part of a premarket notification filed by Berkowits School Of Electrolysis, Inc. with the FDA for Berkowits 2200 Short Wave (thermolysis Epilator).
| Device ID | K860056 |
| 510k Number | K860056 |
| Device Name: | BERKOWITS 2200 SHORT WAVE (THERMOLYSIS EPILATOR) |
| Classification | Epilator, High Frequency, Needle-type |
| Applicant | BERKOWITS SCHOOL OF ELECTROLYSIS, INC. 107-25 METROPOLITAN AVE. Forest Hills, NY 11375 |
| Contact | Barry Herman |
| Correspondent | Barry Herman BERKOWITS SCHOOL OF ELECTROLYSIS, INC. 107-25 METROPOLITAN AVE. Forest Hills, NY 11375 |
| Product Code | KCW |
| CFR Regulation Number | 878.5350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-06 |
| Decision Date | 1986-02-05 |