iSR’obot Mona Lisa 2.0
K-Number: K213411 · 2021-12-22
Device Summary
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 2021-12-22. The listed applicant is Biobot Surgical Pte., Ltd.. The 510(k) number is K213411.
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 2021-12-22, under 510(k) number K213411.
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
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.