Product Code: FTZ FDA class 1 21 CFR 886.4445

Locator, Magnetic

Ophthalmic

A magnetic locator is a device used in ophthalmic or surgical settings to detect the presence and location of magnetic foreign bodies within tissue, guiding their retrieval. It is classified as FDA Class 1 (lowest risk), subject to general controls only, and does not require premarket notification. The product code is FTZ, regulated under 21 CFR 886.4445, within the Ophthalmic medical specialty. This device is exempt from GMP requirements.

510(k)s
2
FEI Numbers
5
Registration Numbers
5
Unique Applicants
2
Years Active
1

Research product code FTZ in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Basic Information

Product Code
FTZ
Device Class
FDA class 1
Regulation Number
886.4445
Medical Specialty
Ophthalmic
Review Panel
OP
Submission Type
4

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

Loading...

Related 510(k) Clearances

This FDA classification is associated with 2 510(k) clearances via K numbers.

K Number Device Name
K833229 SUN BED BY VERRE ET QUARTZ UVA-FRANCE
K830468 MODEL 200

FEI Numbers

This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.