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FDA 510(k)

iSR`obot Mona Lisa 2.0

K-Number: K232320 · 2023-12-21

Decision Date2023-12-21
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

iSR`obot Mona Lisa 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Biobot Surgical Pte., Ltd.. It received FDA 510(k) clearance on 2023-12-21 under 510(k) number K232320. 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 iSR`obot Mona Lisa 2.0?

iSR`obot Mona Lisa 2.0 is a medical device that received FDA 510(k) clearance on 2023-12-21. The listed applicant is Biobot Surgical Pte., Ltd.. The 510(k) number is K232320.

When did iSR`obot Mona Lisa 2.0 receive FDA 510(k) clearance?

iSR`obot Mona Lisa 2.0 received FDA 510(k) clearance on 2023-12-21, under 510(k) number K232320.

Who is the listed applicant for iSR`obot Mona Lisa 2.0?

The FDA 510(k) record lists Biobot Surgical Pte., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for iSR`obot Mona Lisa 2.0?

The FDA product code for iSR`obot Mona Lisa 2.0 is IYO.

Other records listing Biobot Surgical Pte., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: IYO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.