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FDA 510(k)

QUASAR BLUE LIGHT THERAPY SYSTEM

K-Number: K093963 · 2010-08-27

ApplicantSilver Bay, LLC
Decision Date2010-08-27
Product CodeOLP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

QUASAR BLUE LIGHT THERAPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Silver Bay, LLC. It received FDA 510(k) clearance on 2010-08-27 under 510(k) number K093963. The device is classified under product code OLP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUASAR BLUE LIGHT THERAPY SYSTEM?

QUASAR BLUE LIGHT THERAPY SYSTEM is a medical device that received FDA 510(k) clearance on 2010-08-27. The listed applicant is Silver Bay, LLC. The 510(k) number is K093963.

When did QUASAR BLUE LIGHT THERAPY SYSTEM receive FDA 510(k) clearance?

QUASAR BLUE LIGHT THERAPY SYSTEM received FDA 510(k) clearance on 2010-08-27, under 510(k) number K093963.

Who is the listed applicant for QUASAR BLUE LIGHT THERAPY SYSTEM?

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

What is the FDA product code for QUASAR BLUE LIGHT THERAPY SYSTEM?

The FDA product code for QUASAR BLUE LIGHT THERAPY SYSTEM is OLP.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Silver Bay, LLC 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.

K112362C100 WRINKLE REDUCTION DEVICEK111286QUASAR CALYPSOK091467BABY QUASARK072767QUASAR BLUE LIGHT THERAPY SYSTEM

Related Devices (Code: OLP)

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.

K253878LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)Shenzhen Kaiyan Medical Equipment Co., Ltd.K251843Erchonia EVRLErchonia CorporationK242068LED Light Therapy Mask (RT01)Ningbo Dechang Electrical Machinery Made Co.,LtdK243555LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)Shenzhen Eyco Technology Co., Ltd.K232656BLU TOTALE (Model: ENEOB852)Premier North America, Inc.K230490PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA, 4004-LPUR-NA, 4004-CABLUE-NA-INT, 4004-GREY-INT, 4004-YELLOW-INT, 4004-PSTO-INT, 4004-LPUR-INTDongguan Hunter Electronic Technology Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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