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FDA 510(k)

Thermage CPT System and Accessories

K-Number: K173759 · 2018-01-08

ApplicantSolta Medical
Decision Date2018-01-08
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Thermage CPT System and Accessories is a medical device manufactured by Solta Medical. It received FDA 510(k) clearance on 2018-01-08 under approval number K173759. 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 CPT System and Accessories?

Thermage CPT System and Accessories is a medical device that received FDA 510(k) clearance on 2018-01-08. It is manufactured by Solta Medical. The 510(k) number is K173759.

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

Thermage CPT System and Accessories received FDA 510(k) clearance on 2018-01-08, under approval number K173759.

What company makes Thermage CPT System and Accessories?

Thermage CPT System and Accessories is manufactured by Solta Medical.

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

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

Related Clinical Trials

Other Devices by Solta Medical

Related Devices (Code: GEI)

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.