Recall Z-0517-2013— Quasar Bio-Tech, Inc. dba Silver Bay LLC

Name: FDA recall Z-0517-2013
Creator: U.S. Food and Drug Administration
Published: 2012-10-25

Class II · Terminated

Class II FDA medical device recall by Quasar Bio-Tech, Inc. dba Silver Bay LLC, initiated 2012-10-25, terminated 2013-05-21. It names one FDA 510(k) clearance: K051046. Product: Baby Quasar (LAB-001-D, BQ101) and Baby Quasar Pink (LAB-046-A BQ101-P) are infrared LED lamps that are labeled in part: "***BABY QUASAR***FOR YOUTHFUL RADIANT SKIN***Skin Rejuvenating System with Sequepulse***Manufactured by: Silver Bay, LLC; Made in the USA, with highest quality components and durable aluminum. Five Year Warranty The product emits energy in the near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature. This device may be used to provide temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm. This device may temporarily increase local blood circulation, and may be used to promote relaxation of the muscle tissue.. Reason: Quasar Bio-Tech is recalling their Baby Quasar, Baby Quasar Pink, Quasar Power Pack, and Quasar MD because the device is unapproved..

Recalling firm: Quasar Bio-Tech, Inc. dba Silver Bay LLC
Classification: Class II
Status: Terminated
Initiated: 2012-10-25
Terminated: 2013-05-21
Firm location: Sarasota, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K051046 — PAINACEA MODEL XR8 INFRARED HEAT LAMPAtlantis Luminescent Products, LLC·cleared 2005-05-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Baby Quasar (LAB-001-D, BQ101) and Baby Quasar Pink (LAB-046-A BQ101-P) are infrared LED lamps that are labeled in part: "***BABY QUASAR***FOR YOUTHFUL RADIANT SKIN***Skin Rejuvenating System with Sequepulse***Manufactured by: Silver Bay, LLC; Made in the USA, with highest quality components and durable aluminum. Five Year Warranty The product emits energy in the near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature. This device may be used to provide temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm. This device may temporarily increase local blood circulation, and may be used to promote relaxation of the muscle tissue.

Reason for recall

Quasar Bio-Tech is recalling their Baby Quasar, Baby Quasar Pink, Quasar Power Pack, and Quasar MD because the device is unapproved.

Data sourced from openFDA. This site is unofficial and independent of the FDA.