Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3— 510(k) K161198
Substantially EquivalentUsa Laser Biotech, Inc.
FDA 510(k) clearance K161198 for Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3, Substantially Equivalent on 2016-07-26. Applicant: Usa Laser Biotech, Inc.. Device class: 2.
Clearance details
- Applicant
- Usa Laser Biotech, Inc.
- Product code
- Code ILY
- Device class
- Class 2
- Regulation
- 21 CFR 890.5500
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Richmond, VA, US
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More clearances from Usa Laser Biotech, Inc.
view all- K160947 — LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX CPS 4 IR Lamp System LUMIX CPS 5 IR Lamp System
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- K052814 — LUMINA 1600, 3300 AND 6600 SYSTEMS
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Adverse events under product code ILY
product code ILY- Death
- 3
- Total
- 3
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.