iSR`obot Mona Lisa 2.0
K-Number: K232320 · 2023-12-21
ApplicantBiobot Surgical Pte., Ltd.
Decision Date2023-12-21
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
iSR`obot Mona Lisa 2.0 is a medical device manufactured by Biobot Surgical Pte., Ltd.. It received FDA 510(k) clearance on 2023-12-21 under approval 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. It is manufactured by Biobot Surgical Pte., Ltd.. The 510(k) number is K232320.
When was iSR`obot Mona Lisa 2.0 approved by the FDA?
iSR`obot Mona Lisa 2.0 received FDA 510(k) clearance on 2023-12-21, under approval number K232320.
What company makes iSR`obot Mona Lisa 2.0?
iSR`obot Mona Lisa 2.0 is manufactured by Biobot Surgical Pte., Ltd..
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.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.