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FDA 510(k)

SOLARC / SOLRX HANDHELD ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY

K-Number: K061589 · 2006-08-04

ApplicantSolarc Systems, Inc.
Decision Date2006-08-04
Product CodeFTC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SOLARC / SOLRX HANDHELD 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 2006-08-04 under 510(k) number K061589. 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 HANDHELD ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY?

SOLARC / SOLRX HANDHELD ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY is a medical device that received FDA 510(k) clearance on 2006-08-04. The listed applicant is Solarc Systems, Inc.. The 510(k) number is K061589.

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

SOLARC / SOLRX HANDHELD ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY received FDA 510(k) clearance on 2006-08-04, under 510(k) number K061589.

Who is the listed applicant for SOLARC / SOLRX HANDHELD 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 HANDHELD ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY?

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

Related Clinical Trials

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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.

K103204SOLARC / SOLRX E-SERIES 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)

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Official Source

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