Lumenis Smart532 Laser System

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/whitening

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
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.