510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K230755Substantially Equivalent

NuEra Tight RF Model OptiStream

Bios S.r.l., Vimodrone, IT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K230755 is the FDA 510(k) clearance record for NuEra Tight RF Model OptiStream, a class II device, cleared for Bios S.R.L. on under FDA product code PBX (Massager, Vacuum, Radio Frequency Induced Heat). FDA's definition for product code PBX reads: "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". FDA records list 11 510(k) clearances for Bios S.R.L., from to . As of , FDA records show no recalls naming K230755.

Clearance record

Decision date
Received
(227 days to decision)
Product code
PBX Massager, Vacuum, Radio Frequency Induced Heat
Regulation
21 CFR 878.4400
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Bios S.R.L. Via Guido Rossa 10/12, Vimodrone, IT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PBX

Trailing 12 months
5 clearances under product code PBX in the twelve months to October 2026, March 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code PBX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20262
April 20261
May 20260
June 20260
July 20261
August 20260
September 20261
October 20260