510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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REKNot classified

Research Laser

Unknown
FDA source (opens on fda.gov)

REK is the FDA product code for Research Laser. FDA's definition for this code reads: "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". As of , FDA records hold no 510(k) clearances under this code and 5 recalls.

Classification record

Product code
REK
Device name
Research Laser
FDA 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.
Device class
Not classified
Review panel
Unknown
Submission type
FDA code null
GMP exempt
Yes
Ingested clearances
0
Ingested recalls
5

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code REK.