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FDA 510(k)

CLEARWAVE PHOTOTHERAPY SYSTEM FOR ACNE, MODEL: CWST2

K-Number: K091125 · 2010-09-03

ApplicantVerilux
Decision Date2010-09-03
Product CodeONE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CLEARWAVE PHOTOTHERAPY SYSTEM FOR ACNE, MODEL: CWST2 is the device name listed in this FDA 510(k) record. The listed applicant is Verilux. It received FDA 510(k) clearance on 2010-09-03 under 510(k) number K091125. The device is classified under product code ONE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLEARWAVE PHOTOTHERAPY SYSTEM FOR ACNE, MODEL: CWST2?

CLEARWAVE PHOTOTHERAPY SYSTEM FOR ACNE, MODEL: CWST2 is a medical device that received FDA 510(k) clearance on 2010-09-03. The listed applicant is Verilux. The 510(k) number is K091125.

When did CLEARWAVE PHOTOTHERAPY SYSTEM FOR ACNE, MODEL: CWST2 receive FDA 510(k) clearance?

CLEARWAVE PHOTOTHERAPY SYSTEM FOR ACNE, MODEL: CWST2 received FDA 510(k) clearance on 2010-09-03, under 510(k) number K091125.

Who is the listed applicant for CLEARWAVE PHOTOTHERAPY SYSTEM FOR ACNE, MODEL: CWST2?

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

What is the FDA product code for CLEARWAVE PHOTOTHERAPY SYSTEM FOR ACNE, MODEL: CWST2?

The FDA product code for CLEARWAVE PHOTOTHERAPY SYSTEM FOR ACNE, MODEL: CWST2 is ONE.

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Related Devices (Code: ONE)

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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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