Last synced on 16 May 2025 at 11:05 pm

Research Laser

Page Type
Product Code
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 Classification
N
GMP Exempt?
Yes
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

As product code REK is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.

Research Laser

Page Type
Product Code
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 Classification
N
GMP Exempt?
Yes
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

As product code REK is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.