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
Recommended Actions
- Determine the Risk Group classification of your LIP product
- Implement required labeling based on Risk Group:
- Modified compliance statements
- Warning labels as applicable
- Installation instructions
- For RG2 products exceeding 60% AEL:
- Add special child safety warnings
- Include mounting requirements
- For RG3 products:
- Apply for FDA variance
- Implement restricted distribution controls
- Develop authorized installer program
- Establish measurement and testing procedures according to IEC standards
- Prepare and submit required FDA reports:
- Product reports
- Annual reports
- Variance requests if applicable
- Maintain all required documentation and records
- Implement appropriate safety measures:
- Installation requirements
- Access restrictions
- Power reduction sensors if applicable
- Develop user documentation with required warnings and instructions
- 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
- Product reports and annual reports required
- Variance approval required for RG3 LIPs
- Special distribution restrictions for RG3 LIPs
- Installation must be performed by authorized installers for RG3 LIPs
Relevant Guidances
- Laser Products - Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 Standards
- Alternative Warning Statements for Laser Product User Information
- Laser Products - Performance Standards and Safety Requirements
- Laser Light Shows and Displays: Requirements for Aircraft Safety and Visual Control
- Significant Risk Determination for Investigational Medical Laser Devices
- Classification of Electron Beam Accelerators Used as Laser Energy Sources
- Laser Light Shows and Demonstration Laser Products: Performance Standards and Manufacturer Requirements
- In-House Manufactured Laser Products: Applicability of Federal Performance Standards
- Remote Interlock Connector Requirements for Laser Products
- User Instructions for Medical Laser Products: Safety Information and Radiation Hazard Protection Requirements
- Reproduction of Hazard Warning Labels in User Instructions for Laser Products with Cosmetic Enclosures
- Warning Label Requirements for Multiple Wavelength and Dye Laser Products
Related references and norms
- 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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