SLA= Surveying Leveling and Aligning :beer:
" 3. Question: What design features does CDRH consider specific to SLA lasers?
Answer: Certain design features allow SLA lasers to be used in open spaces or in unrestricted environments to determine and delineate the form, extent, or position of a point, body, or area by taking angular measurement, position or adjust parts in proper relation to one another, or define a plane, level, elevation, or straight line. These design features include:
a.Compact size (i.e. small, lightweight)
b.Battery power
c.Ergonomic design to permit hand-held use
d.An aperture in the laser product's protective housing to transmit laser emission into open space
e.Portability to permit use in open spaces or in unrestricted environments
f.Features that utilize the laser’s straight line emission for surveying, leveling, or alignment
Generally, FDA will consider these design features as evidence that the laser product was designed for one or more of the uses listed in the SLA laser definition at 21 CFR 1040.10(b)(39). Therefore, FDA will generally consider laser products with these design features to fall under the definition of an SLA laser product and to be subject to the requirements identified in 21 CFR 1040.11(b) regardless of whether such laser products are promoted for SLA laser uses. "
From:
Surveying, Leveling, or Alignment Laser Products - Draft Guidance for Industry and Food and Drug Administration Staff
