Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

NuEra Tight RF Model OptiStream

K-Number: K230755 · 2023-10-30

ApplicantBios S.R.L.
Decision Date2023-10-30
Product CodePBX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NuEra Tight RF Model OptiStream is the device name listed in this FDA 510(k) record. The listed applicant is Bios S.R.L.. It received FDA 510(k) clearance on 2023-10-30 under 510(k) number K230755. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NuEra Tight RF Model OptiStream?

NuEra Tight RF Model OptiStream is a medical device that received FDA 510(k) clearance on 2023-10-30. The listed applicant is Bios S.R.L.. The 510(k) number is K230755.

When did NuEra Tight RF Model OptiStream receive FDA 510(k) clearance?

NuEra Tight RF Model OptiStream received FDA 510(k) clearance on 2023-10-30, under 510(k) number K230755.

Who is the listed applicant for NuEra Tight RF Model OptiStream?

The FDA 510(k) record lists Bios S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NuEra Tight RF Model OptiStream?

The FDA product code for NuEra Tight RF Model OptiStream is PBX.

Other records listing Bios S.R.L. 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.

K243445Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)K223856NuEra Tight RF FamilyK223907NuEra Tight RF Model APMD145.M70-USK210867NuEra Tight RF, NuEra Tight RF PlusK201239NuEra Tight Family, EMS Model

View all 10 devices →

Related Devices (Code: PBX)

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.

K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.K260647SPECCHIOEl.En S.P.A.K253261Apollo Quattro (APQ-10M)Weero Co., Ltd.K252888NeoSculpt PlusS&M Medical Co., Ltd.K250734OptiLUV DevicePollogen, Ltd.K250916WinForth (LM-E470KA)Shenzhen Leaflife Technology Co., Ltd.

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.

↑