Healix Assistant
Ask me anything about our products
Quick questions
Powered by Healix AI · Talk to a human

Candela Corp.
Free shipping on orders over $99 · 30-day returns
CANDELA MID IR DIODE LASER SYSTEM is an FDA 510(k)-cleared medical device (K002421) manufactured by Candela Corp.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 2, 2000. Regulation: 8.