The following data is part of a premarket notification filed by Lumenis, Ltd. with the FDA for Lumenis Family Of Disposable Contact Tip Delivery Devices.
| Device ID | K030033 |
| 510k Number | K030033 |
| Device Name: | LUMENIS FAMILY OF DISPOSABLE CONTACT TIP DELIVERY DEVICES |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LUMENIS, LTD. 2400 CONDENSA ST. Santa Clara, CA 95051 |
| Contact | Anne Worden |
| Correspondent | Anne Worden LUMENIS, LTD. 2400 CONDENSA ST. Santa Clara, CA 95051 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-03 |
| Decision Date | 2003-07-21 |
| Summary: | summary |