Lenses, Soft Contact, Extended Wear
Which Manufacturers in China Make This?
Chinese manufacturers registered for this device type are based in Hong Kong: 2 hold an FDA registration.
- Bloom MAX Limited Hong Kong
- Objectt Optik Company Limited Hong Kong, contract manufacturer
How Is LPM Classified?
Lenses, Soft Contact, Extended Wear is FDA product code LPM, Class 3, 21 CFR 886.5925.
How Does It Reach the US Market?
A premarket approval is required: the Class 3 route, granted on clinical evidence rather than on equivalence to an existing device. No approval under this code names a Chinese applicant.
What Do the Recalls Say?
The FDA has recorded 26 recalls under this product code since 2002. None was by a company in China. The root causes the FDA records most often are Process control (5), Employee error (3) and Material/Component Contamination (2).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.
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