510(k) K051046 ยท ILY Lamp, Infrared, Therapeutic Heating
PAINACEA MODEL XR8 INFRARED HEAT LAMP
| Applicant | Atlantis Luminescent Products, LLC, Houston TX, US |
| Decision | Substantially Equivalent, May 10, 2005 |
| Received | Apr 25, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051046
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 12, 2012 | Quasar Bio-Tech, Inc. dba Silver Bay LLC 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 Se Terminated |
ILY | None listed |
| Dec 12, 2012 | Quasar Bio-Tech, Inc. dba Silver Bay LLC Quasar MD is an infrared LED lamp that is labeled in part: "***QUASAR MD***Bringing the Spa Home***Radiant and Youthful Skin***QUASAR MD INCLUDES***QUASAR MD***USER MANUAL***12 VOLT POWER SUPPLY***1 O Terminated |
ILY | None listed |
| Dec 12, 2012 | Quasar Bio-Tech, Inc. dba Silver Bay LLC 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 Q Terminated |
ILY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.