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FDA 510(k)

CLEAR+BRILLIANT TOUCH® Laser System

K-Number: K223647 · 2022-12-29

ApplicantSolta Medical, Inc.
Decision Date2022-12-29
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CLEAR+BRILLIANT TOUCH® Laser System is a medical device manufactured by Solta Medical, Inc.. It received FDA 510(k) clearance on 2022-12-29 under approval number K223647. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLEAR+BRILLIANT TOUCH® Laser System?

CLEAR+BRILLIANT TOUCH® Laser System is a medical device that received FDA 510(k) clearance on 2022-12-29. It is manufactured by Solta Medical, Inc.. The 510(k) number is K223647.

When was CLEAR+BRILLIANT TOUCH® Laser System approved by the FDA?

CLEAR+BRILLIANT TOUCH® Laser System received FDA 510(k) clearance on 2022-12-29, under approval number K223647.

What company makes CLEAR+BRILLIANT TOUCH® Laser System?

CLEAR+BRILLIANT TOUCH® Laser System is manufactured by Solta Medical, Inc..

What is the FDA product code for CLEAR+BRILLIANT TOUCH® Laser System?

The FDA product code for CLEAR+BRILLIANT TOUCH® Laser System is GEX. This falls under the Gastroenterology category.

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Related PubMed Literature

PMID: 40407411 A data augmentation approach for an automatic speech recognition system using laser Doppler vibrometer technology. JASA express letters (2025)

Related Devices (Code: GEX)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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