invisa-RED ELITE— 510(k) K192275
Substantially EquivalentIR Technology, LLC
FDA 510(k) clearance K192275 for invisa-RED ELITE, Substantially Equivalent on 2020-08-19. Applicant: IR Technology, LLC. Device class: 2.
Clearance details
- Applicant
- IR Technology, LLC
- Product code
- Code OLI
- Device class
- Class 2
- Regulation
- 21 CFR 878.5400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Woodstock, GA, US
Recent devices under product code OLI
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