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
What You Need to Know? 👇
What are Laser Illuminated Projectors (LIPs) and how are they regulated by FDA?
LIPs are demonstration laser products that project display images without raster-scanned collimated laser beams. They’re regulated under 21 CFR 1040.10(b)(13) and must undergo classification according to FDA requirements, though FDA allows alternative IEC standards for qualified products.
What IEC standards can be used for LIP classification instead of FDA requirements?
FDA accepts IEC 62471-5:Ed. 1.0 for Risk Group classification of qualified LIPs that meet specific criteria. This standard categorizes LIPs into Risk Groups 0-3 based on photobiological safety, providing an alternative to traditional laser class requirements.
What are the key requirements for LIPs to qualify for IEC standard compliance?
LIPs must not be children’s toys or medical devices, cannot produce scanned laser radiation, must serve as conventional projector alternatives, pass IEC 60825-1:Ed. 3 radiance limits, and meet specific RG2 applicability restrictions based on source angular extent.
Do RG3 LIPs require FDA variance approval for commercial use?
Yes, RG3 LIPs are considered equivalent to Class IIIb or IV lasers and require FDA variance approval under 21 CFR 1010.4. They’re typically approved only for cinema theaters or laser light show manufacturers with existing variances.
What special labeling is required for RG2 LIPs exceeding 60% of emission limits?
RG2 LIPs exceeding 60% of accessible emission limits must display “WARNING: MOUNT ABOVE THE HEADS OF CHILDREN” near the staring prohibited symbol, with black text on orange background, plus installation instructions recommending ceiling mounting.
What reporting requirements apply to LIP manufacturers under this guidance?
Manufacturers must submit product reports using Form FDA 3632, maintain annual reports, and comply with 21 CFR 1002 recordkeeping requirements. Reports must document compliance with Section III criteria and measurement/classification procedures outlined in the guidance.
What You Need to Do 👇
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