The following data is part of a premarket notification filed by Intermedic Arfran, S.a. with the FDA for Intermedic Diode Laser Family 810nm And 980nm (and The Delivery Accessories That Are Used With Them To Deliver Laser Ene.
| Device ID | K053540 |
| 510k Number | K053540 |
| Device Name: | INTERMEDIC DIODE LASER FAMILY 810NM AND 980NM (AND THE DELIVERY ACCESSORIES THAT ARE USED WITH THEM TO DELIVER LASER ENE |
| Classification | Powered Laser Surgical Instrument |
| Applicant | INTERMEDIC ARFRAN, S.A. 9233 E. NEVILLE AVE. #1128 Meza, AZ 85212 |
| Contact | Klaus Sivec |
| Correspondent | Klaus Sivec INTERMEDIC ARFRAN, S.A. 9233 E. NEVILLE AVE. #1128 Meza, AZ 85212 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-20 |
| Decision Date | 2006-09-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08435259605256 | K053540 | 000 |