Description
An AC-powered slitlamp biomicroscope is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.
Scope & Applicability
Product Classes
3Subject of the guidance document and ISO 10939
The primary device subject to this guidance
The devices that are the subject of this guidance are Class II non-spinal metallic bone screws and washers
Stakeholders
1Allowed value for reporter qualification
Regulatory Context
Attributes
1Safety characteristic to be compared with predicate
Identified Hazards
Hazards
3Potential toxicity requiring risk-minimization procedures like reducing light exposure.
Hazards including UV, IR, and blue-light weighted radiance
Safety concern addressed in the guidance
Related CFR Sections (6)
- 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 →
- 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 →
- 21CFR801.109§ 801.109 Prescription devices.
A device which, because of any potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and hence for which “adequate directions for use” canRead full regulation →
- 21CFR801.1§ 801.1 Medical devices; name and place of business of manufacturer, packer or distributor.
(a) The label of a device in package form shall specify conspicuously the name and place of business of the manufacturer, packer, or distributor.Read full regulation →
- 21CFR807.87§ 807.87 Information required in a premarket notification submission.
Each premarket notification submission shall contain the following information:Read full regulation →
- 21CFR886.1850§ 886.1850 AC-powered slitlamp biomicroscope.
(a) Identification. An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.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)
- Viewing Optics - Sighting Telescope (Laser Notice 8) (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)