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 |