The following data is part of a premarket notification filed by Cynosure, Inc. with the FDA for Asa 'm Family' Diode Laser, Model Mi, Mix5, M6.
| Device ID | K051922 |
| 510k Number | K051922 |
| Device Name: | ASA 'M FAMILY' DIODE LASER, MODEL MI, MIX5, M6 |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | CYNOSURE, INC. 10 ELIZABETH DR. Chelmsford, MA 01824 |
| Contact | George Cho |
| Correspondent | George Cho CYNOSURE, INC. 10 ELIZABETH DR. Chelmsford, MA 01824 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-15 |
| Decision Date | 2005-09-14 |
| Summary: | summary |