Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
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 Gingival 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/whiteningThe 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 Hemangiolymphangiomas 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
The subject Lumenis® Smart532™ Laser System product is a dual port, solid state, frequency doubled, green Nd:GdVO4 surgical laser instrument used in the photothermolysis (photocoagulation) of soft tissue at an operating emission wavelength of 532nm, a wavelength that has been used widely and effectively in the market for procedures in the fields of ophthalmology, ENT (ear, nose & throat), dermatology and dentistry. Compatible delivery devices & accessories for use with the subject Lumenis® Smart532™ Laser System include: Slit lamps, Slit lamp adapters/attachments, Laser Indirect Ophthalmoscopes (LIO), Eye safety filters, Laser links, Array LaserLink, Selecta Trio, Fibers and Endo-ocular and Endo-Oto probes. The device software may be adjusted by Lumenis to fit customer needs within the system overall range of parameters.
Summary parsed at:2026-06-01 06:11:08 UTC
Smart Laser Indirect Ophthalmoscope (LIO); Laser delivery device for Lumenis Novus Spectra Laser System, Lumenis Vision One Laser System, and Lumenis Smart532™ Laser System
1 submission cite K151109 as a predicate