LIGHTWAVE INFRARED LAMPS LW10D AND LW30D— 510(k) K024027
Substantially EquivalentSkytech Enterprises, Inc.
FDA 510(k) clearance K024027 for LIGHTWAVE INFRARED LAMPS LW10D AND LW30D, Substantially Equivalent on 2003-12-03. Applicant: Skytech Enterprises, Inc.. Device class: 2.
Clearance details
- Applicant
- Skytech Enterprises, 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
- Boulder, CO, US
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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.