The following data is part of a premarket notification filed by Cynosure, Inc. with the FDA for Asa 'mphi Family Diode Laser.
| Device ID | K111901 |
| 510k Number | K111901 |
| Device Name: | ASA 'MPHI FAMILY DIODE LASER |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | CYNOSURE, INC. 5 CARLISLE ROAD Westford, MA 01886 |
| Contact | Anthony Burns |
| Correspondent | Anthony Burns CYNOSURE, INC. 5 CARLISLE ROAD Westford, MA 01886 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-05 |
| Decision Date | 2011-11-09 |
| Summary: | summary |