The following data is part of a premarket notification filed by Ddc Technologies, Inc. with the FDA for Polylase Lp.
| Device ID | K040055 |
| 510k Number | K040055 |
| Device Name: | POLYLASE LP |
| Classification | Powered Laser Surgical Instrument |
| Applicant | DDC TECHNOLOGIES, INC. 2980 WAVERLY AVE. Oceanside, NY 11572 |
| Contact | Dmitry Donskoy |
| Correspondent | Dmitry Donskoy DDC TECHNOLOGIES, INC. 2980 WAVERLY AVE. Oceanside, NY 11572 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-12 |
| Decision Date | 2004-04-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860002307046 | K040055 | 000 |
| 00860002307008 | K040055 | 000 |