# K151109: Lumenis Smart532 Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Lumenis, Inc.
- Decided: Oct 30, 2015 after 186 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K022327 (2002). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022327: Novus Spectra, Lumenis, Inc. (2002) Summary page 5.
- K071687: Famili of Iridex IQ Laser Systems, Iridex Corp (2008) Summary page 5.

## Indications for use
The Lumenis® Smart532™ Laser System is indicated for use in Ophthalmic Applications; Ear, Nose and Throat Applications; Dentistry; and Dermatologic Applications as follows: Ophthalmology Diabetic Retinopathy including Macular Edema or Proliferative Retinopathy Proliferative Diabetic Retinopathy (PDR) Retinal Tear Macular Edema or Proliferative Retinopathy associated with Central Retinal Vein Occlusion (CRVO) or Branch Retinal Vein Occlusion (BRVO) Choroidal Neovascularization (CNV) secondary to Age-related Macular Degeneration (AMD) Central Serous Chorioretinopathy (CSCR) Trabeculoplasty for Primary Open Angle Glaucoma (POAG) Iridotomy / Iridoplasty for Angle-Closure Glaucoma (ACG) Ear, Nose and Throat (ENT) Stapedectomy Stapedotomy Myringotomies Lysis of Adhesions Control of Bleeding Removal of Acoustic Neuromas Soft Tissue Adhesion in Micro/Macro Otologic procedures Dermatology Pigmented lesion, including soar lentigine Vascular lesions, including cherry hemangiomas and angiokeratomas Extremeties telangiectases, including facial and leg telangiectases Cutaneous lesions Flat warts Dermatosis Papulosa Nigra Dentistry Frenectomy Treatment of oral mucous cyst Treatment of benign vascular lesions: Capillary hemangioma Hemorrhagic hereditary telangiectasia Capillary/cavernous hemangiomas Lymphangioma AV malformation of the tongue Hermaniolymphangiomas Photocoagulation of superficial vessels Vaporization of superficial blood or lymph containing vessels Treatment of superficial tongue lesions Tissue management and hemostasis for crown and bridge impressions Incision and drainage for abscess Gingivoplasty/Gingivectomy: Operative procedures Crown and bridge, gingival reduction Crown lengthening Hyperplasia (Drug, irritation, Epulus, ...) Hemostasis during dental procedures Operculectomy (Operculotomy) Excisional biopsy Free Ginvical Graft (Adjunct): Hemostasis of donor site Hemostasis of graft site Vestibuloplasty Soften Gutta Percha Treatment of canker sores, herpetic lesions, and aphthous ulcers Laser-assisted bleaching/whitening Device energy delivery options: Energy Delivery Option Indication SmartPulse Diabetic Retinopathy including Macular Edema or Proliferative Retinopathy, Proliferative Diabetic Retinopathy (PDR), Central Serous Chorioretinopathy (CSCR), Macular Edema or Proliferative Retinopathy associated with Branch Retinal Vein Occlusion (BRVO) CW (Continuous Wave) All Indications

Source page: https://510kreport.com/device/K151109
Methodology: https://510kreport.com/methodology