← FDA Medical Device Classifications

Research Laser

REK · Not classified · Unknown

Classification

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

Definition

Product, laser, research/laboratory; A laser under development in and of itself. A laser used for conducting research during development of new data or to improve a process would not be considered a research laser although it is being used in research.

Market data

Cleared 510(k) submissions
0
Registered establishments
0

Source

Authoritative
FDA Device Classification database
Machine
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