FDA 510(k)

iSRobot Mona Lisa 2.0

K-Number: K213411 · 2021-12-22

Decision Date2021-12-22

Product CodeIYO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

iSRobot Mona Lisa 2.0 is a medical device manufactured by Biobot Surgical Pte., Ltd.. It received FDA 510(k) clearance on 2021-12-22 under approval number K213411. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the iSRobot Mona Lisa 2.0?

iSRobot Mona Lisa 2.0 is a medical device that received FDA 510(k) clearance on 2021-12-22. It is manufactured by Biobot Surgical Pte., Ltd.. The 510(k) number is K213411.

When was iSRobot Mona Lisa 2.0 approved by the FDA?

iSRobot Mona Lisa 2.0 received FDA 510(k) clearance on 2021-12-22, under approval number K213411.

What company makes iSRobot Mona Lisa 2.0?

iSRobot Mona Lisa 2.0 is manufactured by Biobot Surgical Pte., Ltd..

What is the FDA product code for iSRobot Mona Lisa 2.0?

The FDA product code for iSRobot Mona Lisa 2.0 is IYO.

Other Devices by Biobot Surgical Pte., Ltd.

K161109iSR'obot MRI-US Fusion K163502iSR'obot Biopsy Kit K203659iSR'obot Mona Lisa 1.0 K232320iSR`obot Mona Lisa 2.0

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.