NuEra Tight RF Model OptiStream

FDA 510(k) K230755 · Bios S.R.L.

Substantially Equivalent

510(k) numberK230755

Submission

Device name
NuEra Tight RF Model OptiStream
Applicant
Bios S.R.L.
Vimodrone, IT
Received
March 17, 2023
Decision date
October 30, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
PBX – Massager, Vacuum, Radio Frequency Induced Heat
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4400
Specialty
General, Plastic Surgery

Generates heat in body tissues for minor relief of minor aches and pain. Mechanical massaging to provide a temporary reduction in the appearance of cellulite.

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Questions and answers

When was NuEra Tight RF Model OptiStream cleared by the FDA?

NuEra Tight RF Model OptiStream (K230755) received a 510(k) decision of Substantially Equivalent on October 30, 2023, 227 days after the submission was received.

What is the product code of K230755?

The FDA product code is PBX – Massager, Vacuum, Radio Frequency Induced Heat, a Class II (moderate risk) device regulated under 21 CFR 878.4400.