# FDA 510(k) cleared: iTero Lumina™ Pro

> fda · VERIFIED · 2026-07-02

Applicant: Align Technology , Ltd. · Substantially Equivalent

- Company: Align Technology , Ltd.
- Sector: medical devices
- Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261847

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Source: MedFuel Intel news monitor. Verification tier: VERIFIED. Informational only, not investment advice. Corrections: media@medfuelinc.com.