← FDA Medical Device Classifications

High-Power Laser Light Show

REB · Not classified · Unknown

Classification

FDA Product Code
REB
Device class
Not classified
Regulation
Review panel
Medical specialty
Unknown
Submission type
GMP exempt
Y
Life sustaining
Implant
Third-party review

Definition

Product, laser, demo, laser light show/display, class iiib/iv/3b/4; Laser light show or demonstration using laser projection equipment having an output that exceeds 5mw

Market data

Cleared 510(k) submissions
0
Registered establishments
0

Source

Authoritative
FDA Device Classification database
Machine
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