Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Candela CorporationLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Candela Laser Corp. with 43 510(k) clearances. The most recent is a 510(k) clearance dated Aug 15, 1996: ANDELA DYNAMIC COOLING DEVICE.
| Aug 15, 1996 | ANDELA DYNAMIC COOLING DEVICEK951033 · IMD | 510(k) clearances |
| Jun 14, 1996 | CANDELA Q-SWITCHED ALEXANDRITE LASERSK955662 · GEX | 510(k) clearances |
| Apr 3, 1996 | CANDELA HCS 2000 URETHERAL WARMER CATHETERK955011 · GEH | 510(k) clearances |
| Feb 5, 1996 | CANDELA CRYO-PROBE HOLDERK954872 · GEH | 510(k) clearances |
| Feb 2, 1996 | CANDELA SPTL LONG PULSE/TUNABLE PULSED DYE LASEK954934 · GEX | 510(k) clearances |
| Oct 24, 1995 | CANDELA MODEL PLTL-1 LASER SYSTEMK953412 · GEX | 510(k) clearances |
| Oct 18, 1995 | CANDELA CRYOSYSTEM CS-5K953294 · GEH | 510(k) clearances |
| May 26, 1995 | ALEXLAZRK950831 · GEX | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
