Atlas FDA

Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite and Leisure Select)

FDA 510(k) clearance K180576 · decided 2018-04-19

Clearance details

K-number
K180576
Device name
Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite and Leisure Select)
Applicant
Lpi, Inc.
Decision
Substantially Equivalent
Date received
2018-03-05
Decision date
2018-04-19
Days to decision
45 days
Clearance type
Traditional
Product code
LEJ
Device class
2
Regulation number
878.4635
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Johnson City, TN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.