510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Bios S.r.l.

VIMODRONE Milano, IT

BIOS S.R.L. appears in FDA device records in VIMODRONE Milano, IT. FDA records list 11 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
11
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 11 510(k) clearances for Bios S.r.l. between 2015 and 2024. The busiest year on record is 2023, with 3. The most recent is 2024, with 2.

Clearances by year, as a table
510(k) clearance decisions for Bios S.r.l., by decision year
YearClearances
20151
20162
20202
20211
20233
20242
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K243445Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)GEXSubstantially Equivalent
K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)GEXSubstantially Equivalent
K230755NuEra Tight RF Model OptiStreamPBXSubstantially Equivalent
K223856NuEra Tight RF FamilyGEISubstantially Equivalent
K223907NuEra Tight RF Model APMD145.M70-USPBXSubstantially Equivalent
K210867NuEra Tight RF, NuEra Tight RF PlusPBXSubstantially Equivalent
K201239NuEra Tight Family, EMS ModelNGXSubstantially Equivalent
K200359NuEra Tight, NuEra Tight EMSPBXSubstantially Equivalent
K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)GEXSubstantially Equivalent
K153229SuperbiumGEXSubstantially Equivalent
K151296Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250)PBXSubstantially Equivalent

Registered establishments

FDA registered establishments for Bios S.r.l., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30049406773008108972BIOS S.R.L.VIA GUIDO ROSSA, 10/12, VIMODRONE Milano I-20055 IT2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0052-2018THERMI250 Radiofrequency System. Intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions.In some systems, the unit continues to emit RF energy after the PAUSE button is pressed.Class IITerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain