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FDA Warning Letter Explorer
FDA warning letter · Medical Devices

Cutera, Inc.

Issued · Posted by FDA

FDA published a close-out letter on Oct 18, 2024. The passages below are from the original warning letter.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

No separately extracted passage is available. Read the original FDA letter for the full text.

Citations in the original letter

As cited in this historical letter, not a statement of current regulatory requirements.

  • 21 CFR 807.81(a)(3)(ii)

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