Data / Medical devices / Canada / Dectronique (1984) Inc. Dba Dectro International
Dectronique (1984) Inc. Dba Dectro International: FDA-registered device maker in Quebec, Canada, 2 510(k) clearances
Dectronique (1984) Inc. Dba Dectro International is registered with the FDA (registration 9680762) in Quebec, Canada. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 22, 2013. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9680762
- FEI number
- 3001446810
- Address
- 1000 Du Parc-Technologique Blvd, Quebec, Canada, G1P 4S3
- Owner or operator
- DECTRO INTL., INC. (9011218)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- August 17, 1994
- Registered through
- 2026
- Brand names listed
- APILUS CLEO, APILUS JUNIOR 3G, APILUS PLATINUM, APILUS PLATINUM PURE, APILUS SENIOR 3G, APILUS XCELL PUR/PRO, PRO-TEC ISOBLEND F1-F2-F3-F4-F5 PROBES, PRO-TEC ISOGARD F1-F2-F3-F4-F5 PROBES and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Brush, Dermabrasion, Powered | GFE | 1 | Manufacturer | accessdata.fda.gov |
| Epilator, High Frequency, Needle-Type | KCW | 1 | Manufacturer | accessdata.fda.gov |
| Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | ONF | 2 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| January 22, 2013 | K122995 | INTENSE PULSED LIGHT (IPL) SYSTEMS | ONF | Substantially Equivalent | Beijing Kes Biology Technology Co., Ltd. | accessdata.fda.gov |
| January 12, 1995 | K943928 | APILUS ELECTROPIL | KCW | Substantially Equivalent | Dectro Intl., Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Epilator, High Frequency, Needle-Type
- All makers of Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
- All makers of Brush, Dermabrasion, Powered
Updated January 22, 2013. 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.