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FDA 510(k)

QUASAR CALYPSO

K-Number: K111286 · 2012-01-18

ApplicantSilver Bay, LLC
Decision Date2012-01-18
Product CodeOLP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

QUASAR CALYPSO 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 2012-01-18 under 510(k) number K111286. 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 CALYPSO?

QUASAR CALYPSO is a medical device that received FDA 510(k) clearance on 2012-01-18. The listed applicant is Silver Bay, LLC. The 510(k) number is K111286.

When did QUASAR CALYPSO receive FDA 510(k) clearance?

QUASAR CALYPSO received FDA 510(k) clearance on 2012-01-18, under 510(k) number K111286.

Who is the listed applicant for QUASAR CALYPSO?

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 CALYPSO?

The FDA product code for QUASAR CALYPSO 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.

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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 DEVICEK091467BABY QUASARK093963QUASAR BLUE LIGHT THERAPY SYSTEMK072767QUASAR 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

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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