DTR
0
- Joined
- Jun 24, 2010
- Messages
- 5,680
- Points
- 113
They are not too bright. Here is what I sent them today. I can just hope they get their heads out of their ass.
Here is the required proof directly from the FDA website itself for regulation 21 CFR 1040
Full text
CFR - Code of Federal Regulations Title 21
Relevant sections to components designed for incorporation into lasers systems.
Sec. 1040.10 Laser products.
(a)Applicability. The provisions of this section and 1040.11, as amended, are applicable as specified to all laser products manufactured or assembled after August 1, 1976, except when:
(1) Such a laser product is either sold to a manufacturer of an electronic product for use as a component (or replacement) in such electronic product, or
(2) Sold by or for a manufacturer of an electronic product for use as a component (or replacement) in such electronic product, provided that such laser product:
(ii) Is labeled with a statement that it is designated for use solely as a component of such electronic product and therefore does not comply with the appropriate requirements of this section and 1040.11 for complete laser products, and
(iii) Is not a removable laser system as described in paragraph (c)(2) of this section;
Definition of laser system
(23)Laser system means a laser in combination with an appropriate laser energy source with or without additional incorporated components. See paragraph (c)(2) of this section for an explanation of the term "removable laser system."
Here is the required proof directly from the FDA website itself for regulation 21 CFR 1040
Full text
CFR - Code of Federal Regulations Title 21
Relevant sections to components designed for incorporation into lasers systems.
Sec. 1040.10 Laser products.
(a)Applicability. The provisions of this section and 1040.11, as amended, are applicable as specified to all laser products manufactured or assembled after August 1, 1976, except when:
(1) Such a laser product is either sold to a manufacturer of an electronic product for use as a component (or replacement) in such electronic product, or
(2) Sold by or for a manufacturer of an electronic product for use as a component (or replacement) in such electronic product, provided that such laser product:
(ii) Is labeled with a statement that it is designated for use solely as a component of such electronic product and therefore does not comply with the appropriate requirements of this section and 1040.11 for complete laser products, and
(iii) Is not a removable laser system as described in paragraph (c)(2) of this section;
Definition of laser system
(23)Laser system means a laser in combination with an appropriate laser energy source with or without additional incorporated components. See paragraph (c)(2) of this section for an explanation of the term "removable laser system."