Data / Medical devices / United Kingdom / Assembly Contracts Ltd
Assembly Contracts Ltd: FDA-registered device maker in Manchester Lancashire, United Kingdom, 3 510(k) clearances
Assembly Contracts Ltd is registered with the FDA (registration 3010314781) in Manchester Lancashire, United Kingdom. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated March 15, 2005. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010314781
- Address
- Ledson Road Roundthorn Industrial Estate, Manchester Lancashire, United Kingdom, M23 9GP
- Owner or operator
- Assembly Contracts Ltd (10043236)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- January 31, 2013
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| March 15, 2005 | K043317 | OMNILUX PLUS | ILY | Substantially Equivalent | Photo Therapeutics Limited | accessdata.fda.gov |
| July 17, 2003 | K030426 | OMNILUX RED | GEX | Substantially Equivalent | Photo Therapeutics Limited | accessdata.fda.gov |
| June 18, 2003 | K030883 | OMNILUX BLUE | GEX | Substantially Equivalent | Photo Therapeutics Limited | accessdata.fda.gov |
Compare with other makers
Updated March 15, 2005. 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.