FDA applicant
Lumenis, Inc.
FDA records 78 decisions for Lumenis, Inc. (Santa Clara, CA) from 1979 to 2022: 75 510(k) clearances, 1 De Novo grant and 2 original PMA approvals. Most are in product codes GEX (Powered Laser Surgical Instrument) and FTC (Light, Ultraviolet, Dermatological). Since 2016 its 510(k)s took a median of 58 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 208 predicates, 75 of them its own earlier devices. 11 recalls are linked to its devices, 1 Class I.
FDA’s records also spell it “Lumenis, Ltd.”, “Lumenis”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Lumenis, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2026 so far, outlined.
Recalls per year
2in 2025
Class I Class II/III not classified
Planning a device like Lumenis, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Lumenis”
FDA records each applicant name separately; these may or may not be the same firm.