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FDA 510(k)

FRAXEL RE:STORE DUAL LASER SYSTEM: MODEL, MC-SYS-SR1500-D-US

K-Number: K101490 · 2010-09-08

ApplicantThermage, Inc.
Decision Date2010-09-08
Product CodeONG
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FRAXEL RE:STORE DUAL LASER SYSTEM: MODEL, MC-SYS-SR1500-D-US is the device name listed in this FDA 510(k) record. The listed applicant is Thermage, Inc.. It received FDA 510(k) clearance on 2010-09-08 under 510(k) number K101490. The device is classified under product code ONG. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FRAXEL RE:STORE DUAL LASER SYSTEM: MODEL, MC-SYS-SR1500-D-US?

FRAXEL RE:STORE DUAL LASER SYSTEM: MODEL, MC-SYS-SR1500-D-US is a medical device that received FDA 510(k) clearance on 2010-09-08. The listed applicant is Thermage, Inc.. The 510(k) number is K101490.

When did FRAXEL RE:STORE DUAL LASER SYSTEM: MODEL, MC-SYS-SR1500-D-US receive FDA 510(k) clearance?

FRAXEL RE:STORE DUAL LASER SYSTEM: MODEL, MC-SYS-SR1500-D-US received FDA 510(k) clearance on 2010-09-08, under 510(k) number K101490.

Who is the listed applicant for FRAXEL RE:STORE DUAL LASER SYSTEM: MODEL, MC-SYS-SR1500-D-US?

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 FRAXEL RE:STORE DUAL LASER SYSTEM: MODEL, MC-SYS-SR1500-D-US?

The FDA product code for FRAXEL RE:STORE DUAL LASER SYSTEM: MODEL, MC-SYS-SR1500-D-US is ONG.

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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.

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Related Devices (Code: ONG)

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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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