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FDA 510(k)

THERMAGE THERMACOOL NXT SYSTEM AND ACCESSORIES

K-Number: K090580 · 2009-06-26

ApplicantSolta Medical, Inc.
Decision Date2009-06-26
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

THERMAGE THERMACOOL NXT SYSTEM AND ACCESSORIES 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 2009-06-26 under 510(k) number K090580. 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 THERMACOOL NXT SYSTEM AND ACCESSORIES?

THERMAGE THERMACOOL NXT SYSTEM AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 2009-06-26. The listed applicant is Solta Medical, Inc.. The 510(k) number is K090580.

When did THERMAGE THERMACOOL NXT SYSTEM AND ACCESSORIES receive FDA 510(k) clearance?

THERMAGE THERMACOOL NXT SYSTEM AND ACCESSORIES received FDA 510(k) clearance on 2009-06-26, under 510(k) number K090580.

Who is the listed applicant for THERMAGE THERMACOOL NXT SYSTEM AND ACCESSORIES?

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 THERMAGE THERMACOOL NXT SYSTEM AND ACCESSORIES?

The FDA product code for THERMAGE THERMACOOL NXT SYSTEM AND ACCESSORIES is GEI.

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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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