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FDA 510(k)

Thermage FLX System and Accessories

K-Number: K170758 · 2017-09-22

ApplicantSolta Medical
Decision Date2017-09-22
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Thermage FLX System and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Solta Medical. It received FDA 510(k) clearance on 2017-09-22 under 510(k) number K170758. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Thermage FLX System and Accessories?

Thermage FLX System and Accessories is a medical device that received FDA 510(k) clearance on 2017-09-22. The listed applicant is Solta Medical. The 510(k) number is K170758.

When did Thermage FLX System and Accessories receive FDA 510(k) clearance?

Thermage FLX System and Accessories received FDA 510(k) clearance on 2017-09-22, under 510(k) number K170758.

Who is the listed applicant for Thermage FLX System and Accessories?

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

What is the FDA product code for Thermage FLX System and Accessories?

The FDA product code for Thermage FLX System and Accessories is GEI.

Other records listing Solta Medical as applicant

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Related Devices (Code: GEI)

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Official Source

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

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