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The LightMed TruScan 577 Laser System is intended for use in the treatment of ocular pathology in the posterior segment; Retinal photocoagulation, panretinal photocoagulation, focal photocoagulation and grid photocoagulation for vascular and structure abnormalities of the retina and choroid including: - 1. Proliferative and Severe and very severe nonproliferative diabetic retinopathy - 2. Clinically Significant Macular edema - 3. Choroidal neovascularization - 4. Branch and central retinal vein occlusion - 5. The treatment of choroidal neovascularization associated with wet age-related macular degeneration - 6. Lattice degeneration - 7. Retinal tears and detachments

LightMed TruScan 577 is an integrated system consisting of Laser Console utilizing a 577nm Optically Pumped Semiconductor (OPSL; solid state) laser cavity, TruScan integrated Slit Lamp technology controlled via a LCD touch panel and wheel chair accessible ophthalmic instrument table. The TruScan module which is integrated Slitlamp with safety filter as Laser Delivery System, employs a traditional single spot treatment laser, as well as a semi-automated pattern generation method employing short 577mm laser pulse durations of typically 10ms; range of spot size from 50um to 400µm in a continuous adjustment. The LightMed TruScan 577 Laser System is comprised of the following functional components: - LCD touch panel - Laser Console ● - Ophthalmic Instrument table - TruScan integrated CSO Slitlamp (K992836)

LightLas 577/670 is an ophthalmic laser instrument intended for use by ophthalmologists. The 577 mm wavelength laser is indicated for retinal and pan-retinal photocoagulation. endophotocoagulation, macular photocoagulation to treat leaking vessels. and laser trabeculoplasty. The 670 mm wavelength laser is indicated for retinal and pan-retinal photocoagulation.

LightLas577/670 Multi-Wavelength Medical Laser System consists of a Laser Console where the Laser is housed along with the Electronic Control system and Power Supplies and various Laser Delivery Units (LDU's). The LDU's include: Slitlamp Integrated into CSO model SL980. (K992836) . Sirilamp Attachment for CSO model SL990 (K992836) and other Haag Streit clones. . Sittlamp Attachment for Zeiss model SL30 Stitlamp (K862004) . Laser Indirect Ophthalmoscope (LIO) using a Heine Omega 500. (K123316) ● . Laser Indirect Ophthalmoscope (LIO) using a Keeler All pupil II (K854244) 0 . Endophotocoagulation Handpieces (K122905) The LightLas 577/670 Multi-Wavelength Medical Laser System may be used at either the 577 nm wavelength or the 670 nm wavelength. The 577 nm wavelength source can be delivered through both output ports (Ports 1 and 2) of the laser console, while the 670 mm wavelength source is delivered through Port 1 only. Users may choose either wavelength from a LCD touch screen, and only one output port and one wavelength may be selected for use at a time. Laser wavelength selection of the system is indicated on the panel and controlled by system software.

Ophthalmology: 532nm Laser - Retinal Photocoagulation - Pan Retinal Photocoagulation - Endophotocoagulation - Macular photocoagulation to treat leaking vessels - Laser Trabeculoplasty 670nm Laser - Retinal/Pan Retinal Photocoagulation The intended use has not changed from the predicate devices (K052777, K022181, K042785, and K091534)

The LightLas 532/670 system consists of a Laser Console where the Multi-Wavelength Laser is housed along with the Electronic Control system and Power Supplies and various Laser Delivery Units (LDU's). The LDU's include: - Slitlamp Integrated into CSO model SL980. - Slitlamp Attachment for CSO model SL990 and other Haag Streit clones. - Slitlamp Attachment for Zeiss model SL30 Slitlamp. - Laser Indirect Ophthalmoscope (LIO) using a Heine Omega 180 BIO. - Endophotocoagulation handpieces (Endoprobes).

The LightLas 577 Medical Optical Pumped Semiconductor Laser is intended for use in ophthalmic surgical procedures. A complete list is contained in the Indications for Use Statement. Ophthalmology: - . Retinal Photocoagulation - Pan Retinal Photocoagulation . - Endophotocoagulation ● - Macular Photocoagulation - Laser Trabeculoplasty (to treat Open Angle Glaucoma)

The LightLas 577 Laser beam has a wavelength of 577mm, which is in the visible spectrum and is a Yellow light. A red aiming beam is used to position the treatment Yellow beam prior to delivery. The LightLas 577 is a solid state, Optical Pumped Semiconductor surgical laser. It's an instrument used in the photothermolysis (photocoagulation) of soft tissue at en emission wavelength of 577nm. LightLas LaserLink : Laser delivery adapter that may be coupled to each of the above Selecta models and connected to a currently cleared LightLas 577 retinal photocoagulator to allow use of the slit lamp to deliver 577 nm continuous wave laser energy for retinal photocoagulation. Compatible delivery devices include: slit lamps, slit lamp adapters/ attachments, laser indirect ophthalmoscopes(LIO) and endoprobe.

The Medical Frequency Doubled YAG Laser is intended for use in otolaryngological, dermatological and ophthalmic surgical procedures. A complete list is contained in the Indications for Use Statement. Ophthalmology: - Retinal Photocoagulation . - Pan Retinal Photocoagulation - Endophotocoagulation - Macular Treatments - Laser Trabeculoplasty Otolaryngology: - Stapedectomy - · Stapedotomy - · Myringotomy - · Lysis of adhesions - Control of bleeding - · Removal of acoustic neuromas · - · Soft tissue adhesion in micro/macro otologic procedures. Dermatology: - · Vascular lesion - · Pigmented lesion The intended use has not changed from the predicate devices (K022327, K020071, K062369)

The Medical Frequency Doubled YAG Laser is a solid state, frequency-doubled, green Nd: YAG surgical laser. It's an instrument used in the photothermolysis (photocoagulation) of soft tissue at en emission wavelength of 532nm. LightLas LaserLink : Laser delivery adapter that may be coupled to each of the above Selecta models and connected to a currently cleared LightLas 532 retinal photocoagulator to allow use of the slit lamp to deliver 532 nm continuous wave laser energy for retinal photocoagulation. Compatible delivery devices include: slit lamps, slit lamp adapters/ attachments, laser indirect ophthalmoscopes(LIO) and endoprobe.

LightLas Lpulsa SYL-9000: Photodisruption of ocular tissue using light energy emitted by a Nd: YAG laser, including posterior capsulotomy and pupillary membranectomy. LightLas SeLecTor Deux: Photodisruption of ocular tissue using light energy emitted by a Nd: YAG laser, including posterior capsulotomy, pupillary membranectomy and selective laser trabeculoplasty. LightLas LaserLink : Laser delivery system for use by an ophthalmologist in the treatment of ocular tissue. The laser delivery system is intended for a variety of ophthalmic uses, including the indications specified in the laser operator manual. Refer to the laser operator manual, General Intended Use section. LightLas SecLeTor Trois: (SeLecTor Deux with LightLas 532 or 561 or 810) Photodisruption of ocular tissue using light energy emitted by a Nd: YAG laser, including posterior capsulotomy, and pupillary membranectomy, retinal photocoagulation and selective laser trabeculoplasty. The intended use has not changed from the predicate devices (K081704)

The LightLas Family of Medical Laser System is a fully integrated, high-performance diagnostic slitlamp and therapeutic laser delivery system. The System is also an ophthalmic surgical laser designed for performing photodisruption and photocoagulation. For ocular tissue using laser energy emitted by a Nd: YAG laser including posterior capsulotomy, pupillary membranectomy and selective laser trabeculoplasty. The LightLas Family of Medical Laser System produces short, individual pulses of focused laser light with wavelengths of either 1064nm to 532nm, depending on the selected operational mode. Using a slitlamp microscope and aiming beam, the pulsed light is accurately targeted on a structure within the patient's eye. There are several packages for treatment selectable. The LightLas Family of Ophthalmic Lasers is comprised of: LightLas Lpulsa SYL-9000 (K990075): A Nd: YAG laser providing laser pulses at a wavelength of 1064 nm for use in photodisruption of ocular tissue (posterior capsulotomy and pupillary membranectomy). LightLas SeLecTor Deux: A Nd: YAG laser providing laser pulses at a wavelength of 1064 nm for use in photodisruption or frequency doubled YAG laser pulses at a wavelength of 532nm for use in selective laser trabeculoplasty, depending on the mode selected. LightLas LaserLink : Laser delivery adapter that may be coupled to each of the above Selecta models and connected to a currently cleared LightLas 532/561/810 retinal photocoagulator to allow use of the slit lamp to deliver 532/561/810 nm continuous wave laser energy for retinal photocoagulation. LightLas SeLecTor Trois: A Nd:YAG laser providing laser pulses at a wavelength of 1064 nm for use in photodisruption, Frequency Doubled YAG Laser pulses at a wavelength of 532 nm for use in selective laser trabeculoplasty, or 532 nm continuous wave laser energy for retinal photocoagulation, depending on the mode selected. The Trois is a LighLas SeLecTor Deux with one of LightLas system. LightLas SeLecTor Trois suitable for follow unit: 1. LightLas 532 : K010372 2. LightLas 561: K063297 3. LightLas 810: K021538

The indications of use for this device are: - Retinal Photocoagulation - Pan Retinal Photocoagulation - Macular Photocoagulation - Laser Trabeculoplasty - Laser trabeculoplasty is photocoagulation of trabecular meshwork to treat Open Angle Glaucoma (OAG). - Endocoagulation

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The LightLas 810 Infrared Laser Photocoagulator is indicated for all retinal photocoagulation procedures, such as limited and pan-retinal, transpupillary laser photocoagulation, endophotocoagulation and transscleral photocoagulation, and glaucoma procedures, such as laser trabeculoplasty and iridotomy. The LightLas 810 is used in combination with various delivery systems, such as slitlamps, binocular indirect ophthalmoscopes, endoprobes and transscleral probes.

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