The following data is part of a premarket notification filed by Amd Lasers, Llc with the FDA for Picasso/ Picasso Lite/ Picasso Perio.
| Device ID | K102359 |
| 510k Number | K102359 |
| Device Name: | PICASSO/ PICASSO LITE/ PICASSO PERIO |
| Classification | Powered Laser Surgical Instrument |
| Applicant | AMD LASERS, LLC 7405 WESTFIELD BLVD. Indianapolis, IN 46240 |
| Contact | Amy Szentes |
| Correspondent | Amy Szentes AMD LASERS, LLC 7405 WESTFIELD BLVD. Indianapolis, IN 46240 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-19 |
| Decision Date | 2011-09-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D807115100011 | K102359 | 000 |