FLEX-LASE 600 SERIES ION LASER SYSTEM

{0} 11/08/96 10:55 *000000000000000 + 301 594 2358 NO. 655 008 NOV 26 1996 K963399 Flax-Lase 600 Series Ion Laser American Laser Medical November 7, 1996 # Summary of Safety and Effectiveness Information ## Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92 ## Company Name/Contact: **Company:** American Laser Medical 1832 South 3850 West Salt Lake City, UT 84104 (801) 972-1311, FAX (801) 972-5251 **Contact:** Mr. Daniel Hoefer Regulatory Affairs American Laser Medical 1832 South 3850 West Salt Lake City, UT 84104 (801) 972-1311, FAX (801) 972-5251 ## Name of Device: **Trade Name:** Flax-Lase 600 Series Ion Laser **Common Name:** Dermatology Laser ## Classification: Powered surgical laser instruments are assigned the unique device classification code 79GEX. The published physical description of this device is found in 21 CFR, § 878.4810 (a) (2). This device classification section specifically describes argon laser systems. The American Laser Medical device may be configured as either an argon laser system or as a krypton laser system, however American Laser Medical maintains that there is no substantial difference between argon and krypton lasers for the purpose of classification. Presently, these lasers are considered Class II medical devices. 1 {1} 11/25/96 12:23 *000000000000000000000000000000000000000000000000000000000000000000000000000 NO. 674 D03 Flex-Lase 600 Series Ion Laser American Laser Medical November 7, 1996 ## Description of Device: The Flex-Lase 600 Series Ion Laser submission covers all of the internal parts, subassemblies and components as well as the completed device. The Flex-Lase Model 640 is a continuous wave krypton laser system emitting light at the 568 nm (yellow) and 520/530 nm (green) wavelengths. The Flex-Lase Model 620 is a continuous wave argon laser system emitting light at the 488 nm (blue) and the 514 nm (green) wavelengths. Treatment beam output for the Flex-Lase Model 640 (krypton) is 1.0 Watt (yellow) and 3.0 Watts (yellow-green simultaneous). The power output for the Flex-Lase Model 620 (argon) is 5.5 watts blue-green or 2.0 watts green. The aiming beam is provided by an adjustable intensity incoherent white light source. Exposure times for the Flex-Lase 600 Series Ion Laser (in seconds) are 0.02, 0.05, 0.1, 0.25, 0.5, 1.0, and continuous. Laser activation occurs by footswitch. Overall weight of the system is 112 lbs. (51 kg). The Flex-Lase 600 Series Ion Laser has a footprint of 16 X 24 inches (38 X 60 cm) and is 36 inches (90 cm) high. The electrical power requirement is 208 VAC 40 amp single phase. Cooling is provided by external filtered flow-through tap water at a minimum rate of 2.5 gallons (9.5 liters) per minute. Accessories available for use with the Flex-lase 600 Ion Laser include a focusing handpiece with interchangeable guide tips and/or the Hexascan Mark II. The Flex-laser 600 series is not a computer controlled device. ## Intended Use: The Flex-lase 600 Series Ion Laser is intended for use in the treatment of selected vascular and pigmented lesions of the skin. Laser light of a selected wavelength is used to photocalculate tissue based on the absorption characteristic of the targeted chromophore within the tissue. ## Indications for Use: The Flex-Lase 600 Ion Laser is intended for use in the treatment of selected pigmented and vascularized lesions of the skin. Representative indications for use are: 2 {2} 11/25/96 12:24 +000000000000000 - 301 594 2358 NO. 674 D04 Flex-Lase 600 Series Ion Laser American Laser Medical November 7, 1996 Flex-Lase Model 640 Laser System For vascular lesions: (Yellow - 568 nm) 1. Capillary Hemangioma (port wine hemangioma) 2. Strawberry hemangioma 3. Telangectasia 4. Rosacea For pigmented lesions: (Yellow/Green - 568 nm and 520-530 nm). 1. Freckles 2. Age Spots 3. Cafe-au-lait 4. Lentigo Flex-Lase Model 620 Laser System For Vascular Lesions: (Blue/Green - 488 nm and 514.5 nm) 1. Capillary Hemangioma (port wine hemangioma) 2. Strawberry Hemangioma 3. Telangectasia 4. Rosacea For pigmented lesions: (Green - 514.5 nm) 1. Freckles 2. Age Spots 3. Cafe-au-lait 4. Lentigo Comparison of Device Characteristics: For vascular lesions: The Flex-Lase 600 Ion Laser System is substantially equivalent to the HGM Spectrum K1, the Metalaser Vasculase and the Coherent Artisan already in commercial distribution. The materials, design, intended use, method of manufacture, warnings, cautions, precautions and treatment parameters are substantially the same. For pigmented lesions: The Flex-Lase 600 Series Ion Laser system is substantially equivalent to the HGM Spectrum K1, the Metalaser Vasculase and the Coherent Artisan already in commercial distribution. The 3 {3} 11/08/96 10:56 *000000000000000 + 301 594 2358 NO. 655 D11 Flex-Lase 600 Series Ion Laser American Laser Medical, Inc. November 7, 1996 materials, design, intended use, method of manufacture, warnings, cautions and precautions are substantially the same. Feature comparison tables which follow illustrate the equivalence of features of the Flex-Lase 600 and equivalent available systems. See also appendix II for marketing materials on substantially equivalent devices. 4 {4} 11/08/96 10:56 *00000000000000 + 301 594 2356 NO. 655 D12 # Laser Equivalency Table ## Vascular Lesions | | FLEX-LASE MODEL 620 | FLEX-LASE MODEL 640 | HGM K1 | METALASER VASCULASE | COHERENT ARTISAN | | --- | --- | --- | --- | --- | --- | | Type | Continuous. wave argon | Continuous wave krypton | Continuous Wave krypton | Copper Vapor Laser | Continuous wave Argon/Dye | | Wavelength (nanometers) | 514, or 488/514 | 568, or 568/520- 530 | 568, 520/530 | 511, 578 | 514 only, or 488/514, or 577-630 selectable | | Exposure Time (sec.) | 0.02, 0.05, 0.1, 0.25, 0.5, 1.0, and cont. | Same | 0.05, 0.1, 0.2, 0.5, 1.0, 2.0, 5.0, and continuous | 0.075, 0.1, 0.2, 0.3, and continuous | 0.01, 0.02, 0.05, 0.1, 0.2, 0.5, 1.0, 2.0, 5.0, cont. | | Output Mode | Multimode | Multimode | Multimode | Multimode | Multimode | | Beam Delivery | Handpiece via fiber optic | Handpiece via fiber optic | Handpiece via fiber optic | Handpiece via fiber optic | Handpiece via fiber optic | | Stability of Output Energy | +/- 10% | +/- 10% | +/- 10% | +/- 20% | +/- 5% | | Spot Size (mm) | 0.25, 0.5, 1.0 | 0.25, 0.5, 1.0 | 0.1, 0.2, 1.0 | 0.1, 0.2, 1.0 | 0.1, 0.25, 0.5, 1.0, fixed, variable 0.2-2.5 | | Energy density | 2-30 J/cm² | 2-30 J/cm² | 2-30 J/cm² | 4-15 J/cm² | 2-30 J/cm² | | Aiming beam | Adjust- able in- coherent white light source | Adjustable incoherent white light source | HeNe (633nm) adjustable to 5 mW | HeNe (633 nm) | HeNe (633 nm) | 5 {5} 11/08/96 10:57 +0000000000000000000000000000000000000000000000000000000000 | PARAMETER | FLEX-LASE MODEL 620 | FLEX-LASE MODEL 640 | HOM K1 | METALASER VASCULASE | COHERENT ARTISAN | | --- | --- | --- | --- | --- | --- | | Cooling | Filtered flow-through tap water 2.5 gal/min | Filtered flow-through tap water 2.5 gal/min | Internal liquid cooled | Air-cooled, 40F-80F ambient air temp. | Filtered flow-through tap water 2.5 gal/min | | Electrical Requirements | 208-240 VAC 40 amp single phase 50/60 Hz | 208-240 VAC 40 amp single phase 50/60 Hz | 208-240 VAC 40 amp 50/60 Hz single phase | 208 VAC +/- 10%, 20 amp 60Hz single phase | 208 VAC 50 amp 50/60 Hz 3 phase | | Indications for Vascular lesions | Capillary (port wine) hemangioma, Strawberry hemangioma, Telangec-tasia, Rosacea | Capillary or port wine hemangioma Strawberry hemangioma Telangec-tasia Rosacea | Vascular Lesions (same) | Vascular Lesions (same) | Vascular Lesions (same) | | K Number | | | K913428, K913569 | K903883 | na | {6} 11/08/96 10:57 +0000000000000000000000000000000000000000000000000000000000 NO.655 Laser Equivalency Table Pigmented Lesions | | FLEX-LASE MODEL 620 | FLEX-LASE MODEL 640 | HGM K1 | METALASER VASCULASE | COHERENT ARTISAN | | --- | --- | --- | --- | --- | --- | | Type | Continuous wave argon | Continuous wave krypton | Continuous Wave krypton | Copper Vapor Laser | Continuous wave Argon/Dye | | Wavelength (nanometers) | 514, or 488/514 | 568, or 568/520-530 | 568, 520/530 | 511, 578 | 514 only, or 488/514, or 577-630 selectable | | Exposure Time (sec.) | 0.02, 0.05, 0.1, 0.25, 0.5, 1.0, and cont. | Same | 0.05, 0.1, 0.2, 0.5, 1.0, 2.0, 5.0, and continuous | 0.075, 0.1, 0.2, 0.3, and continuous | 0.01, 0.02, 0.05, 0.1, 0.2, 0.5, 1.0, 2.0, 5.0, cont. | | Output Mode | Multimode | Multimode | Multimode | Multimode | Multimode | | Beam Delivery | Handpiece via fiber optic | Handpiece via fiber optic | Handpiece via fiber optic | Handpiece via fiber optic | Handpiece via fiber optic | | Stability of Output Energy | +/- 10% | +/-10% | +/-10% | +/-20% | +/- 5% | | Spot Size (millimeters) | 0.25, 0.5, 1.0 | 0.25, 0.5, 1.0 | 0.1, 0.2, 1.0 mm | 0.1, 0.2, 1.0 mm | 0.1, 0.25, 0.5, 1.0, fixed, variable 0.2-2.5 mm | | Energy density | 2-30 J/cm² | 2-30 J/cm² | 2-30 J/cm² | 4-15 J/cm² | 2-30 J/cm² | | Aiming beam | Adjustable incoherent white light source | Adjustable incoherent white light source | HeNe (633nm) adjustable to 5 mW | HeNe (633 nm) | HeNe (633 nm) | {7} 11/08/96 10:58 +00000000000000 + 301 594 2358 NO. 655 D15 | PARAMETER | FLEX-LASE MODEL 620 | FLEX-LASE MODEL 640 | HGM K1 | METALASER VASCULASE | COHERENT ARTISAN | | --- | --- | --- | --- | --- | --- | | Cooling | Filtered flow-through tap water 2.5 gal/min | Filtered flow-through tap water 2.5 gal/min | Internal liquid cooled | Air-cooled, 40F-80F ambient air temp. | Filtered flow-through tap water 2.5 gal/min | | Electrical Requirements | 208-240 VAC 40 amp single phase 50/60 Hz | 208-240 VAC 40 amp single phase 50/60 Hz | 208-240 VAC 40 amp 50/60 Hz single phase | 208 VAC +/- 10%, 20 amp 60Hz single phase | 208 VAC 50 amp 50/60 Hz 3 phase | | Indications for Pigmented lesions | Freckles, Age spots, cafe-au-lait, lentigo | Freckles, Age spots, cafe-au-lait lentigo | Pigmented Lesions (same) | Pigmented Lesions (same) | Pigmented Lesions (same) | | K Number | | | K913428, K913569 | K903883 | na |