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Based on limited metadata, this warning letter issued to Curewave Lasers LLC on December 12, 2019, addresses compliance concerns with medical devices, though the specific nature of the violations cannot be determined as the subject line is unavailable. The letter was issued under FDA's medical device regulatory authority, but without access to the full warning letter text, the particular manufacturing, labeling, or operational deficiencies cannot be specified. Companies receiving such letters typically face requirements to take corrective action within a specified timeframe to address FDA's concerns.