Description
The intended purposes of a sunlamp product timer are to provide for reliable control of exposures and to limit acute (and delayed) damage from unintentionally long exposures. However, the maximum timer setting should also allow for selection of exposure times needed to build up and maintain a tan. The maximum timer interval is in no way to be considered as a safe limit; all ultraviolet radiation is potentially hazardous.
Scope & Applicability
Product Classes
1Warning label requirements; Products subject to performance standards and warning labels.
Stakeholders
1Entity responsible for submitting NDINs
Regulatory Context
Attributes
2The action spectrum values are relative to the 296 nm wavelength
Characteristic of UV radiation used to determine timer intervals
Identified Hazards
Hazards
2Risk controlled by the exposure schedule
the exposure schedule and maximum recommended exposure time should be constrained by the potential for erythema
Related CFR Sections (1)
See Also (8)
- CPG Sec. 396.400 Policy on Warned on Sunlamp Products (Status: Final)
- CPG Sec. 300.300 Ineffective Devices - 502(f)(I) Labeling Requirements (Status: Final)
- Exemption from Reporting and Record keeping Requirements for Certain Sunlamp Product Manufacturers (Status: Final)
- Policy on Warning Label Required on Sunlamp Products (Status: Final)
- Policy on Lamp Compatibility (sunlamps) (Status: Final)
- Quality Control Guide for Sunlamp Products (FDA 88-8234) (Status: Final)
- Labeling - Regulatory Requirements for Medical Devices (FDA 89-4203) (Status: Final)
- Photobiomodulation (PBM) Devices - Premarket Notification [510(k)] Submissions: Draft Guidance for Industry and Food and Drug Administration Staff (Status: Draft)