The following data is part of a premarket notification filed by Candela Corp. with the FDA for Candela Gentlelase Ii Dermatological Laser.
| Device ID | K984601 |
| 510k Number | K984601 |
| Device Name: | CANDELA GENTLELASE II DERMATOLOGICAL LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CANDELA CORP. 530 BOSTON POST RD. Wayland, MA 01778 |
| Contact | Jay Caplan |
| Correspondent | Jay Caplan CANDELA CORP. 530 BOSTON POST RD. Wayland, MA 01778 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-28 |
| Decision Date | 1999-02-04 |
| Summary: | summary |