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FDA 510(k)

THERMAGE THERMACOOL II SYSTEM

K-Number: K003183 · 2000-12-08

ApplicantThermage, Inc.
Decision Date2000-12-08
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

THERMAGE THERMACOOL II SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Thermage, Inc.. It received FDA 510(k) clearance on 2000-12-08 under 510(k) number K003183. 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 II SYSTEM?

THERMAGE THERMACOOL II SYSTEM is a medical device that received FDA 510(k) clearance on 2000-12-08. The listed applicant is Thermage, Inc.. The 510(k) number is K003183.

When did THERMAGE THERMACOOL II SYSTEM receive FDA 510(k) clearance?

THERMAGE THERMACOOL II SYSTEM received FDA 510(k) clearance on 2000-12-08, under 510(k) number K003183.

Who is the listed applicant for THERMAGE THERMACOOL II SYSTEM?

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

What is the FDA product code for THERMAGE THERMACOOL II SYSTEM?

The FDA product code for THERMAGE THERMACOOL II SYSTEM is GEI.

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Other records listing Thermage, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K101490FRAXEL RE:STORE DUAL LASER SYSTEM: MODEL, MC-SYS-SR1500-D-USK072849MODIFICATION TO THERMAGE THERMACOOL SYSTEMK052936THERMAGE THERMACOOL SYSTEMK061001THERMASSAGEK053365MODIFICATION TO THERMAGE THERMACOOL SYSTEMK052778THERMAGE THERMACOOL SKIN MARKETING

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Related Devices (Code: 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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