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FDA 510(k)

SOLARC / SOLRX E-SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY

K-Number: K103204 · 2011-04-27

ApplicantSolarc Systems, Inc.
Decision Date2011-04-27
Product CodeFTC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SOLARC / SOLRX E-SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY is the device name listed in this FDA 510(k) record. The listed applicant is Solarc Systems, Inc.. It received FDA 510(k) clearance on 2011-04-27 under 510(k) number K103204. The device is classified under product code FTC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOLARC / SOLRX E-SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY?

SOLARC / SOLRX E-SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY is a medical device that received FDA 510(k) clearance on 2011-04-27. The listed applicant is Solarc Systems, Inc.. The 510(k) number is K103204.

When did SOLARC / SOLRX E-SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY receive FDA 510(k) clearance?

SOLARC / SOLRX E-SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY received FDA 510(k) clearance on 2011-04-27, under 510(k) number K103204.

Who is the listed applicant for SOLARC / SOLRX E-SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY?

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

What is the FDA product code for SOLARC / SOLRX E-SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY?

The FDA product code for SOLARC / SOLRX E-SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY is FTC.

Related Clinical Trials

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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Other records listing Solarc Systems, 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.

K061589SOLARC / SOLRX HANDHELD ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILYK031800SOLARC/SOLRX 500 SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY A NEW MEDICAL DEVICE FAMILY CONSISTING OF 5 MODELS:K935572SOLARC 1000 SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT

Related Devices (Code: FTC)

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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Official Source

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