Solar Compact (G4-1)

FDA 510(k) K240007 · Laborie Medical Technologies, Corp.

Substantially Equivalent

510(k) numberK240007

Submission

Device name
Solar Compact (G4-1)
Applicant
Laborie Medical Technologies, Corp.
Portsmouth, NH, US
Received
January 2, 2024
Decision date
May 6, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FFX – System, Gastrointestinal Motility (Electrical)
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1725
Specialty
Gastroenterology, Urology

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Questions and answers

When was Solar Compact (G4-1) cleared by the FDA?

Solar Compact (G4-1) (K240007) received a 510(k) decision of Substantially Equivalent on May 6, 2024, 125 days after the submission was received.

What is the product code of K240007?

The FDA product code is FFX – System, Gastrointestinal Motility (Electrical), a Class II (moderate risk) device regulated under 21 CFR 876.1725.