Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9680762

FEI Number

3001446810

Entity Name

DECTRONIQUE (1984) INC. DBA DECTRO INTERNATIONAL

City/State/Country

QUEBEC, CA

Establishment Address

1000 Du Parc-Technologique Blvd, QUEBEC G1P 4S3, CA

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

DECTRO INTL., INC. (Owner Number: 9011218)

Owner / Operator Contact Address

1000 BLVD., DU PARC TECHNOLOGIQUE, QUEBEC, QUEBEC, CA-NOTA G1P 4S3, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K122995

PMA Number

N/A

All Registered Proprietary Names

SOPHY SAFINA PUR/PRO PRO-TEC STAINLESS F1-F2-F3-F4-F5 PROBES PRO-TEC ISOBLEND F1-F2-F3-F4-F5 PROBES APILUS JUNIOR 3G APILUS XCELL PUR/PRO PRO-TEC ISOGARD F1-F2-F3-F4-F5 PROBES APILUS CLEO APILUS SENIOR 3G APILUS PLATINUM PURE APILUS PLATINUM

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GFE	Brush, Dermabrasion, Powered	General, Plastic Surgery	Class 1	878.4820	2002-09-07
KCW	Epilator, High Frequency, Needle-Type	General, Plastic Surgery	Class 1	878.5350	1994-08-17
ONF	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect	General, Plastic Surgery	Class 2	878.4810	2020-11-20

Official Correspondent

CLEMENT BEAUMONT

US Agent Details

Jean-Louis Gonella Business: AESTHETICS SYSTEMS USA INC. Email: jjfgonella6@gmail.com Phone: (951) 5474903

Related Public Records

Same Entity

DECTRO INTL., INC.

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
K954031	R. A. Fischer Co. Corp.	COMPU-BLEND EPILATOR	1996-01-05
K192521	Shangdong Huamei Technology Co., Ltd.	Intense Pulsed Light Treatment System	2019-12-06

Similar Registrations

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3012170108	JET TECH EUROPE S.R.L.	Milan Milano, IT
3005450640	EUNSUNG GLOBAL CORP.	Wonju-si Gangwon, KR
3012616488	BRERA MEDICAL INCORPORATED	Northborough, MA, US
3029972466	ASTERASYS CO., LTD.	Seongdong-gu Seoul, KR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9680762. Last updated year: 2026. Please use registration number 9680762 when referencing this establishment in official correspondence.