The following data is part of a premarket notification filed by Lumenis, Inc. with the FDA for Lumenis 1000 Integrated Slit Lamp.
Device ID | K052129 |
510k Number | K052129 |
Device Name: | LUMENIS 1000 INTEGRATED SLIT LAMP |
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 | 2005-08-05 |
Decision Date | 2005-08-30 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07290109143811 | K052129 | 000 |
07290109143712 | K052129 | 000 |