Lapis Lasers Variance Renewal Approval

FDA CDRH approved the renewal of an existing variance for Lapis Lasers & Lighting FX, LLC under Docket No. FDA-2016-V-3709. The variance relates to laser device manufacturing requirements under 21 CFR Part 1040 (Performance Standards for Electronic Products). The approval letter confirms the company may continue operating under the variance terms.

No immediate action is required by other regulated entities. This variance renewal applies specifically to Lapis Lasers & Lighting FX and does not establish new industry-wide requirements. Companies with similar laser device manufacturing operations should continue compliance with existing FDA standards unless they have received separate variance approvals.