Integre Lio
FDA 510(k) K251507 · Quantel Medical
510(k) numberK251507
Submission
- Device name
- Integre Lio
- Applicant
- Quantel Medical
Cournon D'Auvergne-Cedex, FR - Received
- May 16, 2025
- Decision date
- February 6, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HQF – Laser, Ophthalmic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4390
- Specialty
- Ophthalmic
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Questions and answers
When was Integre Lio cleared by the FDA?
Integre Lio (K251507) received a 510(k) decision of Substantially Equivalent on February 6, 2026, 266 days after the submission was received.
What is the product code of K251507?
The FDA product code is HQF – Laser, Ophthalmic, a Class II (moderate risk) device regulated under 21 CFR 886.4390.