Soliton’s Generation II tattoo-removal device receives 510(k) premarket notification

March 11, 2020

Soliton has received 510(k) clearance from the U.S. FDA for its Generation II Rapid Acoustic Pulse (RAP) device for tattoo removal.

Soliton, a medical device company based in Houston, announced today that the U.S. Food and Drug Administration (FDA) has given special 510(k) premarket notification clearance for the company’s Generation II Rapid Acoustic Pulse (RAP) device.1

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Soliton initially filed the 510(k) application with the FDA on Feb. 10, 2020, noting that the devices’ intended use is as an accessory for the 1064 nm Q-Switched laser on black ink in Fitzpatrick Skin Types I-III.

Chris Capelli, M.D., founder, president and CEO of Soliton, says the company intends to distribute the new version of the device to 20-25 of the top U.S. dermatologists for physician feedback and market data on cartridge usage.

“The FDA clearance of our Generation II RAP device marks yet another milestone on Soliton’s path towards commercialization, specifically this year’s strategic launch for tattoo removal,” he says.

The company also announced its recent Manufacturing Services Agreement with Sanmina Corporation, an integrated manufacturing solutions provider. The agreement will allow Sanmina to produce Soliton’s Rapid Acoustic Pulse (RAP) device and its replaceable cartridges, effective March 6.2

“Sanmina’s expertise and world-class service are a great match for Soliton’s innovative device, which is FDA-cleared for tattoo removal and we believe has potential in additional aesthetic indications including cellulite removal and fibrotic scarring, and we look forward to working with them in the years ahead,” says Dr. Capelli, M.D.

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The RAP devices utilize rapid pulses of acoustic shockwaves for the removal of tattoos. The company is also investigating other uses for the device, including fat reduction, cellulite improvement and fibrotic scars treatment, and has already presented promising study results for the latter. Currently, the device is only cleared by the FDA for tattoo removal.

References:

1. Soliton Receives FDA Clearance of Special 510(k). Soliton, Inc. http://ir.soliton.com/news/detail/89/soliton-receives-fda-clearance-of-special-510k. Published March 11, 2020. Accessed March 11, 2020.

2. Soliton signs Agreement with Global Manufacturer Sanmina. Soliton, Inc. http://ir.soliton.com/news/detail/88/soliton-signs-agreement-with-global-manufacturer-sanmina. Published March 9, 2020. Accessed March 11, 2020.

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