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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 a medical device manufactured by Solta Medical. It received FDA 510(k) clearance on 2017-09-22 under approval 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. It is manufactured by Solta Medical. The 510(k) number is K170758.

When was Thermage FLX System and Accessories approved by the FDA?

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

What company makes Thermage FLX System and Accessories?

Thermage FLX System and Accessories is manufactured by Solta Medical.

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

The FDA product code for Thermage FLX System and Accessories is 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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