The following data is part of a premarket notification filed by Lumenis, Inc. with the FDA for Novus Varia Ophthalmic Laser And Delivery Devices With Accessories.
Device ID | K022181 |
510k Number | K022181 |
Device Name: | NOVUS VARIA OPHTHALMIC LASER AND DELIVERY DEVICES WITH ACCESSORIES |
Classification | Powered Laser Surgical Instrument |
Applicant | LUMENIS, INC. 2400 CONDENSA ST. Santa Clara, CA 95051 -0901 |
Contact | Karen L Baker |
Correspondent | Karen L Baker LUMENIS, INC. 2400 CONDENSA ST. Santa Clara, CA 95051 -0901 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-07-03 |
Decision Date | 2002-10-01 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07290109143736 | K022181 | 000 |
07290109143729 | K022181 | 000 |
07290109143668 | K022181 | 000 |
07290109143392 | K022181 | 000 |
07290109143385 | K022181 | 000 |