Recall Z-0519-2013— Quasar Bio-Tech, Inc. dba Silver Bay LLC

Name: FDA recall Z-0519-2013
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: Quasar Power Pack contains a Baby Quasar and a Baby Blue. The Baby Quasar is an infrared LED lamp. The Baby Blue uses blue LED light to be used in combination with the Baby Quasar to treat acne. The Quasar Power Pack is labeled in part: "***BABY QUASAR & BABY BLUE***QUASAR POWERPACK***FOR YOUTHFUL, RADIANT, CLEAR SKIN***SKIN REJUVENATING SYSTEM WITH SEQUEPULSE PLUS ADVANCED ACNE CLARIFYING SYSTEM***Manufactured by: Quasar Biotech, Inc., BPP101 LAB-003-E, ***Made in the USA with highest quality components and durable aluminum. Five Year Warranty.***". 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

Quasar Power Pack contains a Baby Quasar and a Baby Blue. The Baby Quasar is an infrared LED lamp. The Baby Blue uses blue LED light to be used in combination with the Baby Quasar to treat acne. The Quasar Power Pack is labeled in part: "***BABY QUASAR & BABY BLUE***QUASAR POWERPACK***FOR YOUTHFUL, RADIANT, CLEAR SKIN***SKIN REJUVENATING SYSTEM WITH SEQUEPULSE PLUS ADVANCED ACNE CLARIFYING SYSTEM***Manufactured by: Quasar Biotech, Inc., BPP101 LAB-003-E, ***Made in the USA with highest quality components and durable aluminum. Five Year Warranty.***"

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.