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Lumenis Stellar M22

DEN200028 Class II Direct
Decision Date
2021-02-23
Sponsor / Applicant
Lumenis, Ltd.

Technical Specification

510(k) Submission ID DEN200028
Product Code QIU
Medical Specialty / Panel Ophthalmic
Regulation Citation 21 CFR 886.5201
Decision Date 2021-02-23
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

Lumenis Stellar M22 received FDA 510(k) clearance under submission number DEN200028, sponsored by Lumenis, Ltd.. The device was reviewed via the Direct premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2021-02-23.

Classification & Regulation

This clearance is catalogued under FDA product code QIU and 21 CFR 886.5201, within the Ophthalmic review panel as a Class II device.