The company's ThermoLase system is a laser-based process designed to quickly and painlessly remove unwanted hair for the long-term -- a market that it said was worth more than $1 billion a year.
ThermoLase stock jumped $6.25 or 47 percent to $19.50 in midday trading on the American Stock Exchange.
Its parent company, Thermotrex, owns 69 percent of the stock. It jumped $3.875, or 23 percent, to $20.375.
ThermoLase last year conducted trials on the sytem with dermatologists in California and New Jersey who specialize in laser procedures. The application included data on a total of 114 participants, almost all women.
It submitted the test results to the FDA in December. "We are very pleased that the FDA acted so quickly in evaluating our application," said Firooz Rufeh, chairman of ThermoLase. "And we're excited about the opportunity to serve the needs of people in the U.S., who spend the more than $1 billion annually on hair removal."
Under the system, a proprietary lotion is applied to the area being treated. Then, the laser scans the skin, painlessly disabling the unwanted hair.
The company said dermatologists have been using the same type of laser for years, though at higher energy levels, to remove birthmarks and tattoos.
It said the LORAD division of ThermoLase's parent company, ThermoTrex Corporation, is manufacturing the laser.