The following data is part of a premarket notification filed by Candela Laser Corp. with the FDA for Mdl-1 Lasertripter(tm).
| Device ID | K885255 |
| 510k Number | K885255 |
| Device Name: | MDL-1 LASERTRIPTER(TM) |
| Classification | Lithotriptor, Electro-hydraulic |
| Applicant | CANDELA LASER CORP. 530 BOSTON POST RD. Wayland, MA 01778 |
| Contact | George Cho |
| Correspondent | George Cho CANDELA LASER CORP. 530 BOSTON POST RD. Wayland, MA 01778 |
| Product Code | FFK |
| CFR Regulation Number | 876.4480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-23 |
| Decision Date | 1989-06-01 |