The following data is part of a premarket notification filed by Cynosure, Inc. with the FDA for Hilt Family Laser: Hilt I, Hilt Ii, Hilt Iii.
| Device ID | K051537 |
| 510k Number | K051537 |
| Device Name: | HILT FAMILY LASER: HILT I, HILT II, HILT III |
| 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 | 2005-06-10 |
| Decision Date | 2005-09-26 |
| Summary: | summary |