Description
To: All Manufacturers and Potential Manufacturers of Laser ProductsSubject:Applicability of Viewing Optics Performance Requirements to a Sighting Telescope of a Surveying Laser Product
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
2General manual surgical instruments exempt from 510(k)
Product type incorporating a sighting telescope
Stakeholders
1Entity responsible for submitting NDINs
Identified Hazards
Hazards
3Reflection type requiring specific safety warnings
Reflection type requiring specific safety warnings
exposure risks requiring warnings and protective housing
Related CFR Sections (2)
- 21CFR1040.10§ 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:Read full regulation →
- 21CFR1040.11§ 1040.11 Specific purpose laser products.
(a) Medical laser products. Each medical laser product shall comply with all of the applicable requirements of § 1040.10 for laser products of its class. In addition, the manufacturer shall:Read full regulation →
See Also (8)
- Laser Energy Source (Laser Notice 2) (Status: Final)
- Quality Control Practices for Compliance with the Federal Laser Performance Standard (Status: Final)
- Certain Military Lasers Exempt From 21 CFR 1040.10 & .11 (Laser Notice 9) (Status: Final)
- Identification Labels for Certain Class I Laser Products (Laser Notice 48) (Status: Final)
- User Instruction for Medical Products (Laser Notice 44) (Status: Final)
- Class II and IIIA Laser Light Show Projectors and Shows (Laser Notice 40) (Status: Final)
- User Instruction Hazard Warnings (Laser Notice 35) (Status: Final)
- Exemption of Certain Lasers Used By DOE, NOAA and U.S. Dept. of Commerce (Laser Notice 25) (Status: Final)