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 |