Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004940677

FEI Number

3008108972

Entity Name

BIOS S.R.L.

City/State/Country

VIMODRONE Milano, IT

Establishment Address

VIA GUIDO ROSSA, 10/12, VIMODRONE Milano I-20055, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BIOS S.R.L. (Owner Number: 9068895)

Owner / Operator Contact Address

VIA GUIDO ROSSA, 10/12, --, VIMODRONE (MILAN), IT-NOTA I-20090, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K230755

PMA Number

N/A

All Registered Proprietary Names

Splendor X Nd:YAG Splendor X Alex2 Splendor X Alex+Nd:YAG Splendor X Alex Splendor X Alex Splendor X Nd:YAG Splendor X Alex+Nd:YAG Splendor X Alex2 NuEra Tight 1ch

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2024-06-27
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2025-01-13
PBX	Massager, Vacuum, Radio Frequency Induced Heat	General, Plastic Surgery	Class 2	878.4400	2021-10-29
PBX	Massager, Vacuum, Radio Frequency Induced Heat	General, Plastic Surgery	Class 2	878.4400	2023-12-06
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2023-12-06
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-12-06
PBX	Massager, Vacuum, Radio Frequency Induced Heat	General, Plastic Surgery	Class 2	878.4400	2023-06-29
PBX	Massager, Vacuum, Radio Frequency Induced Heat	General, Plastic Surgery	Class 2	878.4400	2023-11-03

Official Correspondent

No official correspondent registered.

US Agent Details

Alessandro Franchi Email: franchi.alessandro@gmail.com Phone: (714) 8182823

Related Public Records

Same Entity

BIOS S.R.L.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K083258	Dornier Medtech America, Inc.	MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE	2009-01-30
K201111	Candela Corporation	GentleMax Pro Plus	2020-05-26
K202758	Shangdong Huamei Technology Co., Ltd.	Nd: YAG Laser Therapy Systems HM-YL900	2020-11-16
K904068	Luxar Corp.	LUXAR MODEL LX-20 CO2 LASER	1991-04-15
K142225	CAO Group, Inc.	Pilot Elite Diode Laser	2014-09-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0005-2014	PhotoMedex, Inc.	2	The product is labeled in part "*Surgical Laser Technologies, Inc. Montgomeryville, PASLT Fiber Delivery SystemSterileNon-Pyrogenic**. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Z-0025-2018	Medtronic Navigation, Inc.	2	VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Z-0028-2007	Lumenis Inc.	2	Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004940677. Last updated year: 2026. Please use registration number 3004940677 when referencing this establishment in official correspondence.