Data / Medical devices / Canada / Precision Technology Services Ltd
Precision Technology Services Ltd: FDA-registered device maker in Cambridge Ontario, Canada, 11 510(k) clearances
Precision Technology Services Ltd is registered with the FDA (registration 3020246591) in Cambridge Ontario, Canada. It lists 6 device types. The FDA files 11 510(k) clearances under its listings, the newest dated April 25, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3020246591
- Address
- 7-38 Cowansview Road, Cambridge Ontario, Canada, N1R 7N3
- Owner or operator
- PRECISION TECHNOLOGY SERVICES, LTD. (9052199)
- Roles
- Exporter to the US
- First device listed
- July 19, 2002
- Registered through
- 2026
- Brand names listed
- Apex Daily Wear, Daily Wear ICD Flexfit, ICD Flexfit, Keratoconus Bi-Aspheric (KBA), MEDMONT VISUAL FUNCTION TESTER, Medmont Automated Perimeter M700 USB, Medmont Automated Perimeter M700 USB C, Medmont Automated Perimeter M700 USB CR and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Chart, Visual Acuity | HOX | 1 | Exporter to the US | accessdata.fda.gov |
| Keratoscope, Ac-Powered | HLQ | 1 | Exporter to the US | accessdata.fda.gov |
| Lens, Contact (Orthokeratology) | MUW | 2 | Exporter to the US | accessdata.fda.gov |
| Lens, Contact (Other Material) - Daily | HQD | 2 | Exporter to the US | accessdata.fda.gov |
| Perimeter, Automatic, Ac-Powered | HPT | 1 | Exporter to the US | accessdata.fda.gov |
| Topographer, Corneal, Ac-Powered | MMQ | 1 | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| April 25, 2018 | K180616 | OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens | HQD | Substantially Equivalent | Contamac, Ltd. | accessdata.fda.gov |
| December 8, 2016 | K162005 | Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens | HQD | Substantially Equivalent | Acuity Polymers, Inc. | accessdata.fda.gov |
| July 13, 2016 | K160859 | OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) | MUW | Substantially Equivalent | Contamac, Ltd. | accessdata.fda.gov |
| October 9, 2008 | K081178 | OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DAILY WEAR CONTACT LENSES | HQD | Substantially Equivalent | Contamac, Ltd. | accessdata.fda.gov |
| August 2, 2007 | K071043 | BOSTON XO (HEXAFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON ES (ENFLUFOCON A) RIGID GAS PERMEABLE CONTACT LENSES | HQD | Substantially Equivalent | Bausch & Lomb, Inc. | accessdata.fda.gov |
| May 1, 2007 | K070628 | OPTIMUM GP (ROFLUFOCON A,B,C,D&E) DAILY WEAR CONTACT LENS. | HQD | Substantially Equivalent | Contamac, Ltd. | accessdata.fda.gov |
| November 1, 2006 | K062548 | MODIFICATION TO OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES | HQD | Substantially Equivalent | Contamac, Ltd. | accessdata.fda.gov |
| January 30, 2006 | K053124 | BOSTON ES (ENFLUFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON XO (HEXAFOCON A) RIGID GAS PERMEABLE CONTACT LENSES | HQD | Substantially Equivalent | Bausch & Lomb, Incorporated | accessdata.fda.gov |
| March 19, 2004 | K033594 | OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES | HQD | Substantially Equivalent | Contamac, Ltd. | accessdata.fda.gov |
| September 12, 2002 | K021977 | HYBRID FS & HYBRID FS TORIC (HYCOFOCON A) RGP CONTACT LENS FOR DAILY WEAR | HQD | Substantially Equivalent | Contamac, Ltd. | accessdata.fda.gov |
| August 22, 2002 | K022128 | BOSTON EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS | HQD | Substantially Equivalent | Bausch & Lomb, Incorporated | accessdata.fda.gov |
Compare with other makers
- All makers of Lens, Contact (Other Material) - Daily
- All makers of Perimeter, Automatic, Ac-Powered
- All makers of Lens, Contact (Orthokeratology)
- All makers of Topographer, Corneal, Ac-Powered
- All makers of Chart, Visual Acuity
- All makers of Keratoscope, Ac-Powered
Updated April 25, 2018. 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.