Candela Laser Corp.
Candela Laser Corp. appears in FDA public data with 0 recalls, 43 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on Aug 15, 1996.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 43
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K951033 | ANDELA DYNAMIC COOLING DEVICE | Aug 15, 1996 |
| K955662 | CANDELA Q-SWITCHED ALEXANDRITE LASERS | Jun 14, 1996 |
| K955011 | CANDELA HCS 2000 URETHERAL WARMER CATHETER | Apr 3, 1996 |
| K954872 | CANDELA CRYO-PROBE HOLDER | Feb 5, 1996 |
| K954934 | CANDELA SPTL LONG PULSE/TUNABLE PULSED DYE LASE | Feb 2, 1996 |
| K953412 | CANDELA MODEL PLTL-1 LASER SYSTEM | Oct 24, 1995 |
| K953294 | CANDELA CRYOSYSTEM CS-5 | Oct 18, 1995 |
| K950831 | ALEXLAZR | May 26, 1995 |
| K946386 | CANDELA RUBY LAZE Q-SWITCHED RUBY LASER | Mar 24, 1995 |
| K950661 | CANDELA 10MM CIRCULAR SPOT LASER HANDPIECE | Mar 10, 1995 |
| K943292 | CANDELA SPTL VARIABLE PULSE/TUNABLE PULSED DYE LASERS | Mar 9, 1995 |
| K950633 | CANDELA URETHRAL/BLADDER SOUND | Mar 6, 1995 |
| K950635 | CANDEKA DUKATIR SETS | Mar 1, 1995 |
| K950634 | CANDELA SHEATH SETS | Mar 1, 1995 |
| K945587 | CANDELA ELLIPTICAL SPOT HANDPIECE | Dec 8, 1994 |
| K940173 | CANDELA Q-SWITCHED ALEXANDRITE LASER | Dec 7, 1994 |
| K921995 | CANDELA H:ERB LASER | Nov 7, 1994 |
| K944090 | CANDELA ALEX LAZR Q-SWITCHED ALEXANDRITE LASER | Sep 30, 1994 |
| K934811 | PLTL-1 & PLDL-1 510NM PULSED DYE LASERS | Sep 1, 1994 |
| K942152 | CANDELA Q-SWITCHED, FREQUENCY DOUBLED ND;YAG LASER SY | Jul 25, 1994 |