The following data is part of a premarket notification filed by Lightwave Technologies Llc with the FDA for Lightwave Professional Deluxe.
| Device ID | K082586 |
| 510k Number | K082586 |
| Device Name: | LIGHTWAVE PROFESSIONAL DELUXE |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LIGHTWAVE TECHNOLOGIES LLC 55 Northern Blvd Suite 200 Great Neck, NY 11021 |
| Contact | Maria F Griffin |
| Correspondent | Maria F Griffin LIGHTWAVE TECHNOLOGIES LLC 55 Northern Blvd Suite 200 Great Neck, NY 11021 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-08 |
| Decision Date | 2010-01-04 |
| Summary: | summary |