The following data is part of a premarket notification filed by Intermedic Arfran, S.a. with the FDA for Modified Intermedic Diode Laser 980nm System (multidiode Sst 200).
| Device ID | K091323 |
| 510k Number | K091323 |
| Device Name: | MODIFIED INTERMEDIC DIODE LASER 980NM SYSTEM (MULTIDIODE SST 200) |
| Classification | Powered Laser Surgical Instrument |
| Applicant | INTERMEDIC ARFRAN, S.A. 3637 BERNAL AVE. Pleasanton, CA 94566 |
| Contact | Anne Worden |
| Correspondent | Anne Worden INTERMEDIC ARFRAN, S.A. 3637 BERNAL AVE. Pleasanton, CA 94566 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-05 |
| Decision Date | 2009-06-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08435259605218 | K091323 | 000 |