Beta Bionics, Inc.
iLet ACE Pump
SKU K253976UPC QFG
In Stock
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IIFDA 510(k) Cleared (K253976)
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Free shipping on orders over $99 · 30-day returns
Beta Bionics, Inc.
Free shipping on orders over $99 · 30-day returns
iLet ACE Pump is an FDA 510(k)-cleared medical device (K253976) manufactured by Beta Bionics, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 29, 2026. Regulation: 8.
