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Berger & Kraft: FDA-registered device maker in RASZYN Mazowieckie, Poland, 4 510(k) clearances

Name: Berger & Kraft FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Berger & Kraft is registered with the FDA (registration 3015779311) in RASZYN Mazowieckie, Poland. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated July 17, 2023. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3015779311
Address: Slowikowski 85 Street, RASZYN Mazowieckie, Poland, 05-090
Owner or operator: Berger & Kraft (10061213)
Roles: Manufacturer
First device listed: September 18, 2019
Registered through: 2026
Brand names listed: ALIYA, EpilMe, LaserMe, Plasma IQ, Sectum, Zaffiro

Devices it lists

Device	Product code	Class	Role	Source
Brush, Dermabrasion, Powered	GFE	1	Manufacturer	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Manufacturer	accessdata.fda.gov
Massager, Vacuum, Radio Frequency Induced Heat	PBX	2	Manufacturer	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 17, 2023	K230077	LaserME	GEX	Substantially Equivalent	Neauvia North America	accessdata.fda.gov
January 17, 2023	K223222	Plasma IQ	GEI	Substantially Equivalent	Neauvia North America, Inc.	accessdata.fda.gov
June 2, 2022	K213261	EpilME	GEX	Substantially Equivalent	Neauvia North America	accessdata.fda.gov
July 30, 2021	K202780	Sectum	PBX	Substantially Equivalent	Neauvia North America	accessdata.fda.gov

Compare with other makers

Updated July 17, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.