The following data is part of a premarket notification filed by Lumenis Ltd with the FDA for Smart Laser Indirect Ophthalmoscope (lio); Laser Delivery Device For Lumenis Novus Spectra Laser System, Lumenis Vision One Laser System, And Lumenis Smart532™ Laser System.
Device ID | K162837 |
510k Number | K162837 |
Device Name: | Smart Laser Indirect Ophthalmoscope (LIO); Laser Delivery Device For Lumenis Novus Spectra Laser System, Lumenis Vision One Laser System, And Lumenis Smart532™ Laser System |
Classification | Powered Laser Surgical Instrument |
Applicant | LUMENIS LTD 6 HAKIDMA STREET PO BOX 240 YOKNEAM INDUSTRIAL PARK Yokneam, IL 2069204 |
Contact | Naama Jacoby |
Correspondent | Naama Jacoby LUMENIS LTD 6 HAKIDMA STREET PO BOX 240 YOKNEAM INDUSTRIAL PARK Yokneam, IL 2069204 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-10-11 |
Decision Date | 2017-02-28 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00810096330215 | K162837 | 000 |
07290109143842 | K162837 | 000 |
07290109143835 | K162837 | 000 |
07290109140612 | K162837 | 000 |