Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite and Leisure Select)— 510(k) K180576
Substantially EquivalentLpi, Inc.
FDA 510(k) clearance K180576 for Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite and Leisure Select), Substantially Equivalent on 2018-04-19. Applicant: Lpi, Inc.. Device class: 2.
Clearance details
- Applicant
- Lpi, Inc.
- Product code
- Code LEJ
- Device class
- Class 2
- Regulation
- 21 CFR 878.4635
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Johnson City, TN, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.