Biomicroscope, Slit-Lamp, Ac-Powered, Exempt
The Biomicroscope, Slit-Lamp, AC-Powered (Exempt) is an ophthalmic instrument that uses a high-intensity light source and a microscope to provide a detailed view of the anterior and posterior segments of the eye, used by clinicians to examine structures such as the cornea, lens, vitreous humor, and retina. Product code PUE is the Class II exempt counterpart of HJO, exempted from the 510(k) requirement under the 21st Century Cures Act, subject to the limitations in 21 CFR 886.9. Under regulation 21 CFR 886.1850, it is a Class II device subject to general and special controls. It falls under the Ophthalmic medical specialty and is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- PUE
- Device Class
- FDA class 2
- Regulation Number
- 886.1850
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 4
Device Characteristics
Definition
This product code is the class II exempt counterpart of HJO, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 886.9 and the specific limitations of exemption as stated in the Physical State field of this product code description.
FEI Numbers
This FDA classification entry is associated with 30 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 30 registration numbers. Click on an entry to view related FDA registrations.