FDA Registration
Active
🇨🇦 Canada
DECTRONIQUE (1984) INC. DBA DECTRO INTERNATIONAL
Reg #: 9680762
·
FEI: 3001446810
·
Expires 2026
Products
3
Proprietary Names
11
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- DECTRONIQUE (1984) INC. DBA DECTRO INTERNATIONAL
- Registration Number
- 9680762
- FEI Number
- 3001446810
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1000 Du Parc-Technologique Blvd
- City
- QUEBEC
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K943928
Owner / Operator
- Firm Name
- DECTRO INTL., INC.
- Operator Number
- 9011218
- Address
- 1000 BLVD., DU PARC TECHNOLOGIQUE
- City
- QUEBEC, QUEBEC
- State
- CA-NOTA
- Postal Code
- G1P 4S3
- Country
- CA
- Correspondent
- CLEMENT - BEAUMONT
US Agent
- Business Name
- AESTHETICS SYSTEMS USA INC.
- Contact Name
- Jean-Louis Gonella
- Address
- 1159 Pomona Rd Ste E
- City
- Corona
- State
- CA
- ZIP
- 92882
- Country
- US
- [email protected]
- Phone
- 951 5474903
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Brush, Dermabrasion, Powered | GFE | Class 1 | General, Plastic Surgery | No | 2002-09-07 |
| Epilator, High Frequency, Needle-Type | KCW | Class 1 | General, Plastic Surgery | No | 1994-08-17 |
| Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | ONF | Class 2 | General, Plastic Surgery | No | 2020-11-20 |
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
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device