The following data is part of a premarket notification filed by Alma Lasers, Inc. with the FDA for Alma Lasers Pixel Co2 Laser System, Delivery Device And Accessories.
| Device ID | K103501 |
| 510k Number | K103501 |
| Device Name: | ALMA LASERS PIXEL CO2 LASER SYSTEM, DELIVERY DEVICE AND ACCESSORIES |
| Classification | Powered Laser Surgical Instrument |
| Applicant | ALMA LASERS, INC. 485 HALF DAY RD. SUITE #100 Buffalo Grove, IL 60089 |
| Contact | Tatiana Epstein |
| Correspondent | Tatiana Epstein ALMA LASERS, INC. 485 HALF DAY RD. SUITE #100 Buffalo Grove, IL 60089 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-29 |
| Decision Date | 2011-01-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17290110120976 | K103501 | 000 |
| 17290110121966 | K103501 | 000 |
| 17290110121959 | K103501 | 000 |
| 17290110122048 | K103501 | 000 |
| 17290110122031 | K103501 | 000 |
| 17290110122024 | K103501 | 000 |
| 17290110122017 | K103501 | 000 |
| 17290110122000 | K103501 | 000 |
| 17290110121997 | K103501 | 000 |
| 17290110122055 | K103501 | 000 |
| 07290110123680 | K103501 | 000 |
| 07290110123741 | K103501 | 000 |
| 17290110121973 | K103501 | 000 |
| 17290110121980 | K103501 | 000 |
| 17290110121737 | K103501 | 000 |
| 17290110120969 | K103501 | 000 |
| 17290110120952 | K103501 | 000 |
| 17290110120815 | K103501 | 000 |
| 17290110120792 | K103501 | 000 |
| 17290110120785 | K103501 | 000 |
| 17290110120778 | K103501 | 000 |
| 17290110120761 | K103501 | 000 |
| 17290110120754 | K103501 | 000 |
| 17290110120747 | K103501 | 000 |
| 17290110120730 | K103501 | 000 |
| 17290110121744 | K103501 | 000 |
| 07290110123888 | K103501 | 000 |