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FDA 510(k)

BLUESHINE'S GOLD SERIES

K-Number: K110375 · 2012-02-23

ApplicantBlueshine Srl
Decision Date2012-02-23
Product CodePDZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BLUESHINE'S GOLD SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Blueshine Srl. It received FDA 510(k) clearance on 2012-02-23 under 510(k) number K110375. The device is classified under product code PDZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLUESHINE'S GOLD SERIES?

BLUESHINE'S GOLD SERIES is a medical device that received FDA 510(k) clearance on 2012-02-23. The listed applicant is Blueshine Srl. The 510(k) number is K110375.

When did BLUESHINE'S GOLD SERIES receive FDA 510(k) clearance?

BLUESHINE'S GOLD SERIES received FDA 510(k) clearance on 2012-02-23, under 510(k) number K110375.

Who is the listed applicant for BLUESHINE'S GOLD SERIES?

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

What is the FDA product code for BLUESHINE'S GOLD SERIES?

The FDA product code for BLUESHINE'S GOLD SERIES is PDZ.

Related Clinical Trials

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Other records listing Blueshine Srl 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.

K090297BLUESHINE GOLD SERIESK063060BLUESHINE LIGHT SHINE SYSTEMS, SP, TWIN AND COMPACT SP

Related Devices (Code: PDZ)

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.

K253960Medicell Mycosis Laser (MCML24004)Medicell Healthcare Co.,LTDK241116Onycho Laser VTerasysd&C, Inc.K211265TFX-LT2000 Therapy LightToefx, Inc.K221363AF LaserShenB Co., Ltd.K190034REMY Medical Therapy Laser SystemFootdocprenur, LLCK153164LunulaLaserErchonia Medical, Inc.

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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