PAINACEA MODEL XR8 INFRARED HEAT LAMP
FDA 510(k) clearance K051046 · decided 2005-05-10
Clearance details
- K-number
- K051046
- Device name
- PAINACEA MODEL XR8 INFRARED HEAT LAMP
- Applicant
- Atlantis Luminescent Products, LLC
- Decision
- Substantially Equivalent
- Date received
- 2005-04-25
- Decision date
- 2005-05-10
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- ILY
- Device class
- 2
- Regulation number
- 890.5500
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Houston, TX, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Baby Quasar (LAB-001-D, BQ101) and Baby Quasar Pink (LAB-046-A BQ101-P) are infrared LED l recall (Z-0517-2013) | Quasar Bio-Tech, Inc. dba Silver Bay LLC | 2012-12-12 |
| Quasar MD is an infrared LED lamp that is labeled in part: "***QUASAR MD***Bringing the Sp recall (Z-0518-2013) | Quasar Bio-Tech, Inc. dba Silver Bay LLC | 2012-12-12 |
| Quasar Power Pack contains a Baby Quasar and a Baby Blue. The Baby Quasar is an infrared L recall (Z-0519-2013) | Quasar Bio-Tech, Inc. dba Silver Bay LLC | 2012-12-12 |