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FDA 510(k)

FRAXEL DUAL 1550/1927 LASER SYSTEM

K-Number: K130193 · 2013-06-14

ApplicantSolta Medical, Inc.
Decision Date2013-06-14
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FRAXEL DUAL 1550/1927 LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Solta Medical, Inc.. It received FDA 510(k) clearance on 2013-06-14 under 510(k) number K130193. 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 FRAXEL DUAL 1550/1927 LASER SYSTEM?

FRAXEL DUAL 1550/1927 LASER SYSTEM is a medical device that received FDA 510(k) clearance on 2013-06-14. The listed applicant is Solta Medical, Inc.. The 510(k) number is K130193.

When did FRAXEL DUAL 1550/1927 LASER SYSTEM receive FDA 510(k) clearance?

FRAXEL DUAL 1550/1927 LASER SYSTEM received FDA 510(k) clearance on 2013-06-14, under 510(k) number K130193.

Who is the listed applicant for FRAXEL DUAL 1550/1927 LASER SYSTEM?

The FDA 510(k) record lists Solta Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FRAXEL DUAL 1550/1927 LASER SYSTEM?

The FDA product code for FRAXEL DUAL 1550/1927 LASER SYSTEM is GEX. This falls under the Gastroenterology category.

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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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