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Laser Illuminated Projectors (LIPs) - Classification, Safety Requirements and Labeling

This guidance applies to Laser Illuminated Projectors (LIPs) that: - Are not children's toys or medical devices - Do not produce scanned laser radiation - Use laser illumination as an alternative to conventional light sources - Pass specific IEC radiance limit thresholds - Meet specific Risk Group 2 (RG2) criteria based on source angular extent and emissions

  1. Determine the Risk Group classification of your LIP product
  2. Implement required labeling based on Risk Group:
    • Modified compliance statements
    • Warning labels as applicable
    • Installation instructions
  3. For RG2 products exceeding 60% AEL:
    • Add special child safety warnings
    • Include mounting requirements
  4. For RG3 products:
    • Apply for FDA variance
    • Implement restricted distribution controls
    • Develop authorized installer program
  5. Establish measurement and testing procedures according to IEC standards
  6. Prepare and submit required FDA reports:
    • Product reports
    • Annual reports
    • Variance requests if applicable
  7. Maintain all required documentation and records
  8. Implement appropriate safety measures:
    • Installation requirements
    • Access restrictions
    • Power reduction sensors if applicable
  9. Develop user documentation with required warnings and instructions
  10. Establish quality control procedures to ensure ongoing compliance

Key Considerations

Non-clinical testing

  • Must conduct measurements for classifying LIPs according to IEC 62471-5 Ed. 1.0 Subclause 5.2.2
  • Classification measurements must include all exit pupil radiation from lasers, phosphors and LEDs
  • Must classify projector according to Risk Groups (RG0, RG1, RG2, RG3)

Human Factors

  • Special requirements for LIPs exceeding 60% of RG2 AEL:
    • Warning label “MOUNT ABOVE THE HEADS OF CHILDREN”
    • Installation instructions requiring ceiling mounting above children’s eyes
  • Supervision requirements for children
  • Caution requirements for remote control use
  • Warning against using optical aids in beam

Labelling

  • Modified compliance statements required on certification label
  • RG0 and RG1 specific labeling requirements
  • Warning labels for RG2 and RG3 products
  • “Not for household use” label for RG3 products

Safety

  • Installation height requirements for RG3 LIPs (minimum 3m vertical height)
  • Horizontal clearance requirements (2.5m)
  • Restricted access requirements for hazard zones
  • Power reduction sensors allowed as safety measure

Other considerations

  • IEC 60825-1 Ed. 3.0: Safety of laser products - Part 1: Equipment classification and requirements
  • IEC 62471-5 Ed. 1.0: Photobiological safety of lamps and lamp systems - Part 5: Image projectors

Original guidance

  • Laser Illuminated Projectors (LIPs) - Classification, Safety Requirements and Labeling
  • HTML / PDF
  • Issue date: 2019-05-08
  • Last changed date: 2019-05-07
  • Status: FINAL
  • Official FDA topics: Medical Devices, Radiation-Emitting Products, Radiological Health
  • ReguVirta summary file ID: 653c69f085555d5f59384119fda6a7c1
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