The following data is part of a premarket notification filed by Candela Corp. with the FDA for Candela Model Mdl-1 Laser Lithotriptor.
| Device ID | K863642 |
| 510k Number | K863642 |
| Device Name: | CANDELA MODEL MDL-1 LASER LITHOTRIPTOR |
| Classification | Lithotriptor, Electro-hydraulic |
| Applicant | CANDELA CORP. 19 STRATHMORE RD. Natick, MA 01760 |
| Contact | Horace Furumoto |
| Correspondent | Horace Furumoto CANDELA CORP. 19 STRATHMORE RD. Natick, MA 01760 |
| Product Code | FFK |
| CFR Regulation Number | 876.4480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-17 |
| Decision Date | 1986-12-03 |