Product Code: RES FDA not classified

Laser Pointer

Unknown

The Laser Pointer is a handheld laser product designed to indicate a specific point of interest, commonly used in presentations, education, and other settings where highlighting a location on a surface is needed. This product is classified as FDA Not Classified (Class N) with product code RES and is GMP-exempt. It has no associated regulation number or medical specialty, as it is a general consumer or commercial product rather than a medical device. No implant or life-sustaining flags are noted. Laser pointers are regulated by the FDA under the electronic product radiation control provisions rather than as medical devices.

510(k)s
0
FEI Numbers
0
Registration Numbers
0
Unique Applicants
0
Years Active

Basic Information

Product Code
RES
Device Class
FDA not classified
Medical Specialty
Unknown

Device Characteristics

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

Definition

Product, laser, pointer, indicate point of interest; A laser product intended specifically to define a spot or surface for drawing attention to a viewer.