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General intended use: Suprema Family is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization and coagulation of body soft tissues in the medical specialties of dermatology, general, plastic and oral surgery as follows. Indications for use: 1064 nm (pulsed): Intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis. The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratosis and plaques. The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. The laser is also indicated for the treatment of facial wrinkles. Additionally, the laser is indicated for the treatment of pseudofolliculitis barbae (PFB) and for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime. It is indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. The laser is also indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. It is indicated for use on all skin types (Fitzpatrick I-VI) including tanned skin, and the removal and permanent reduction of unwanted hair in Fitzpatrick I-VI, including suntanned skin types. 532 nm (pulsed): Intended for the coagulation and hemostasis of vascular lesions. For photocoagulation and hemostasis of vascular and cutaneous lesions in dermatology including but not limited to the following general categories: vascular lesions [angiomas, hemangiomas (port wine), telangiectasia (facial or ex-tremities telangiectasias, venous anomalies, leg veins]; benign pigmented lesions (nevi, lentigines, chloasma, cafe au- lait, tattoos (red and green ink), verrucae, skin tags, keratoses, plaques, cutaneous lesion treatment (hemostasis, color lightening, flattening, reduction of lesion size). 755 nm (pulsed): Indicated for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs re-growing when measured 6, 9, or 12 months after the completion of a treatment regime. It is used for all skin types (Fitzpatrick I-VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles. IPL 590-1200nm; 625-1200nm; 650-1200nm: Indicated for permanent hair removal. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. IPL 550-1200nm; 570-1200nm: Indicated for photocoagulation of dermatological vascular lesion (i.e. face telangiectasia), photothermolysis of blood vessels (treatment of facial and leg veins), and treatment of benign pigmented lesions. IPL 400-1200nm: Indicated for inflammatory acne (acne vulgaris). Integrated Skin Cooler: The intended use of the integrated cooling system in Suprema Family is to provide cooling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluences for laser treatments such as hair removal and vascular lesion, and to reduce the potential side effects of laser treatments.

Suprema family includes medical laser devices for dermatology and aesthetic medicine. It is used by health care professionals (dermatologists) in professional healthcare environments for the treatment of different skin conditions and hair removal. Suprema models differ for the installed laser sources only according to Table 1. Suprema devices are transportable mobile electrical equipment with a graphical user interface (GUI) for user-device interaction. Laser radiation is delivered through optical fibers connected to handpieces having fix or variable spot dimension. The device can be optionally equipped with an integrated skin cooler. In this case, a specific housing called Skin Cooler handpiece is provided to provide skin cooling the laser handpiece at the same time. Configurations without optional integrated skin cooler, can be used in conjunction with Cryo 6 skin cooler manufactured by Zimmer GmbH (K060395). In this case, an optional housing is provided which is called Skin Cryo handpiece. Laser handpieces cannot be used alone but only in conjunction to Skin Cooler and Skin Cryo handpieces. Laser emission can be activated by the footswitch or by a finger-switch placed on Skin Cooler and Skin Cryo handpieces. The device can be divided into four main sections: Power electronics, Control electronics, Cooling system, Optical bench. Suprema devices can be used in conjunction with Twain 2940 devices. Twain IPL and Twain 2940 are already FDA cleared (K202503, K173002, respectively).

General intended use The Discovery Pico Family is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization and coagulation of body soft tissues in the medical specialties of dermatology, general, plastic and oral surgery as follows. Indications for use 1064 & 532 nm (Q-Switched, nanosecond mode) The Discovery Pico Family is intended for treatment of benign vascular lesions, benign pigmented lesions, and for hair, tattoo removal and the incision, ablation, vaporization of soft tissue for General dermatology such as, but not limited to treatment of: 532 nm (Q-Switched, nanosecond mode), including microbeam handpieces: Removal of light ink (red. sky blue, green, tan, purple, and orange) tattoos Treatment of benign vascular lesions including, but not limited to: - port wine birthmarks - telangiectasias - spider angiomaa - Cherry angioma - Spider nevi - Treatment of benign pigmented lesions including, but not limited to: - cafe-au-Iait birthmarks - Ephalides, solar lentigines - senile lentigines - Becker's nevi - freckles - common nevi - nevus spilus - Ota Nevus - Treatment of seborrheic keratosis Treatment of post inflammatory hyperpigmentation Skin resurfacing procedures for the treatment of acne scars and wrinkles. 1064 nm (Q-Switched, nanosecond mode), including microbeam handpieces: Removal of dark ink (black, blue and brown) tattoos Removal of benign pigmented lesions including; - nevus of Ota - Café au lait spot - Ephalides, solar lentigo (lentigines) - Becker Nevus - Nevus spilus - Treatment of common nevi Removal or lightening of unwanted hair Skin resurfacing procedures for the treatment of acne scars and wrinkles 1064 nm (non Q-Switched - free running mode) Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned skin. Photocoagulation and hemostasis of benign pigmented and benign vascular lesions, such as, but not limited to port wine stains, hemaongiomae, warts, telangiectasiae, rosacea, venus lake, leg veins and spider veins. Coagulation and hemostasis of soft tissue. Treatment of wrinkles. Treatment of mild to moderate inflammatory acne vulgaris. 532 nm (picosecond mode), also with fractional and microbeam handpieces: Indicated for the removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange. Indicated for benign pigmented lesions removal for Fitzpatrick skin types I-IV. Only with fractional handpiece, indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV 1064 nm (picosecond mode), also with fractional and microbeam handpieces: Indicated for the removal of tattoos for all skin types (Fitzpatrick skin types I-VI) to treat the following tattoo colors: black, brown, green, blue and purple. Indicated for benign pigmented lesions removal for Fitzpatrick skin types I-IV. Only with fractional handpiece, indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV Only with fractional handpiece, indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V 694 nm (O-Switched), including microbeam handpieces Indicated for: Tattoo removal: Suggested for blue, sky blue, black, green and violet ink Pigmented lesion removal (benign): - Cafe au lait spot - Ephalides, solar lentigo lentigines) - Becker Nevus - Ota and Ito Nevus - Nevus spilus - Mongolian spot 694 nm (non q-switch - free running mode) Intended to remove benign dermal pigmented lesions, and, to effect hair removal of patients with skin types 1-4 through selective targeting of melanin in hair follicles in dermatology and plastic surgery. IPL 590-1200nm; 625-1200nm; 650-1200nm Indicated for permanent hair removal. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime IPL 550-1200nm; 570-1200nm Indicated for photocoagulation of dermatological benign vascular lesion (i.e. face telangiectasia), photothermolysis of blood vessels (treatment of facial and leg veins), and treatment of benign pigmented lesions. IPL 400-1200nm Indicated for inflammatory acne (mild to moderate acne vulgaris). Integrated Skin Cooler The intended use of the integrated cooling system in the laser hand piece is to provide cooling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluencies for laser treatments such as hair removal and benign vascular lesson, and to reduce the potential side effects of laser treatments. Any other different use is considered incorrect.

The Discovery Pico Family is a laser family that includes Q-Switched and/or Pulsed laser sources, emitting at one or more of the following wavelengths: 532 nm, 1064 nm, 694 nm (Ruby laser) The Discovery Pico Family systems, through the special universal Twain connector, can be equipped with intense pulsed light handpieces (Twain IPL) emitting at the following wavelengths: 650-1200nm, 625-1200nm, 590-1200nm, 570-1200nm, 550-1200nm, 400-1200nm. lt can also be connected to Er:YAG handpieces cleared under K173002. The Discovery Pico Family systems, when operating with Pulsed laser sources and IPL, can be used in combination with optional contact, or air, cooling systems. The optical delivery system is an articulated arm with fixed handpieces. The optical delivery system for the IPL system is a handpiece (Twain IPL) with fixed or interchangeable light filters at different wavelengths. All the models belonging to the Discovery Pico Family have the same components and the same controlling software. The only difference between different models is the optical bench that depends on the sources installed. The Discovery Pico Family is controlled via a touch screen display housed in the front of the device. Emission is triggered by means of a footswitch.

INTENDED USE The device Litho including a fiber optic delivery system is intended to be used in surgical procedures such as open. laparoscopic and endoscopic, to perform incision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue and in Lithotripsy of stones. INDICATIONS FOR USE The device Litho including a fiber optic delivery system is indicated for use in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue and in Lithotripsy of stones in medical specialties including, but not limited to: - Urology - Gastroenterology - Arthroscopy - Neurosurgery - Pulmonary - Gynecology - ENT - Dermatology - Plastic Surgery - General Surgery

The modified device Litho is a Laser surgical instrument for use in general and plastic surgery and in dermatology (GEX). Both devices are Pulsed Holmium: YAG laser with a maximum output power of 30 W @ 2.1 um. The device Litho including a fiber optic delivery system is intended to surgical procedures such as open, laparoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue and in Lithotripsy of stones.

INTENDED USE The device Litho DK30 including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue and in Lithotripsy of stones. INDICATIONS FOR USE The device Litho DK30 including a fiber optic delivery system is insurgical procedures such as open, laparoscopic and endoscopic, to perform incision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue and in Lithotripsy of stones in medical specialties including, but not limited to: - Urology - · Gastroenterology - Arthroscopy - Neurosurgery - Pulmonary - Gynecology - ENT - Dermatology - Plastic Surgery - General Surgery

The modified device Litho DK30 is a Laser surgical instrument for use in general and plastic surgery and in dermatology (GEX). This Special 510(k) of the modified device Litho DK30 is submitted due to Device Modifications of the already cleared device Litho (K091909): Litho DK30 is the desktop version of the already cleared device Litho (K09109). Both devices are Pulsed Holmium:YAG laser with a maximum output power of 30 W @ 2.1 um. The device Litho including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue and in Lithotripsy of stones.

Quanta Systems Surgical Laser Fibers are intended to be used in conjunction with any cleared surgical laser manufactured by Quanta system equipped with SMA 905 connector. Quanta Systems Surgical Laser Fibers are indicated for use in general surgery applications for: incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in a contact mode (with a compatible laser marketed for use in the desired application). Quanta System Surgical Laser Fibers (surgical fiber optic laser delivery devices) are indicated for use in general surgery, urology, gastroenterology, dermatology, vascular surgery, neurosurgery, plastic surgery. ENT/ololaryngology, endovenous occlusion of the greater saphenous vein in the patient with superficial vein reflux and laser assisted lipolysis with an approved compatible laser marketed for use in the desired application. Quanta System Surgical Laser Fibers are also indicated for use in open or closed endoscopic applications where incision, excision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors or lesions, tissue vaporization, hemostasis and or coagulation may be indicated with an approved compatible laser marketed for use in the desired application. Quanta System Surgical Laser Fibers are also intended as an aid for otologic procedures, for use in incision, excision, coagulation and vaporization of soft and fibrous tissue including osseous tissue with an approved compatible laser marketed for use in the desired application. Quanta System Surgical Laser Fibers are also indicated for use in lithotripsy with an approved compatible laser marketed for use in the desired application. Quanta System Surgical Laser Fibers are indicated for use with laser devices emitting radiation from 532 nm to 2100 nm, with pulsed and continuous wave (CW) emission mode. Quanta System Surgical Laser Fibers are indicated, but not limited, for use with Diode laser, Argon, KTP/532, Ho:YAG, Nd;YAG, Tm:YAG pulsed and continuous wave CW laser devices. Quanta System Surgical Laser Fibers may be used in surgical specially or procedures for which compatible lasers have received regulatory clearance: for a complete information about applications, contraindications, precautions and warnings when using fiber optic it is necessary to refer to the applicable laser device User Manual.

The Quanta System Surgical Laser Fibers are surgical fiber optic laser delivery devices based on a silica core/silica clad fiber jacketed with ethylene tetraffluoroethylene (ETFE). The devices are 3.0 meters (9.8 ft) in length and are terminated with a laser specific SMA 905 connector plus a strain relief on the proximal end. Different distal tip configurations and various core diameter sizes (150, 200, 272, 365, 400, 800 and 1000 microns) are offered. The Quanta System Surgical Laser Fibers are single-use sterile medical devices, supplied sterilized by Ethylene Oxide (EtO).

YOULASER CO2 laser when used in traditional, non fractionated mode is indicated for: incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otorhinolaryngology (ENT), gynaecology, neurosurgery, dental and oral surgery and genitourinary surgery. YOULASER CO2 laser when used in fractionated mode (dot scanner) is indicated only for ablative skin resurfacing.

The YOULASER CO2 Laser System includes a single model named YOULASER CO2 emitting a maximum power of 30 Watt at 10.6 µm. The YOULASER CO2 Laser is composed externally of a metallic shell with a frontal polyurethane panel containing the touch screen display. On this panel the key switch, emergency red push button and the operation led are inserted too. On the rear panel the footswitch connector, the remote interlock, the power switch are located. The laser system is composed of power supply, CO2 laser source with air cooling system, optical bench, articulated arm with CO2 scanner, the control electronics. The electronic, based on a microcontroller, manages the voltage power supply and the CO2 laser source.

YOULASER CO2 Laser is indicated for incision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otolaryngology (ENT), gynaecology, neurosurgery, dental and oral surgery and genitourinary surgery. YOULASER CO2 Laser with the scanning unit is indicated for full ablative skin resurfacing for the following application: Dyschromia, Atrophic + Acne scars, Hypertrophic scars The scanning modality is intended for the above described use. In this case the handpiece simply enables a laser-tissue interaction in different positions within a specific area. The safety and effectiveness of this scanner/device has not been evaluated as a fractionated scanner/device

The YOULASER CO2 Laser System includes 1 model: YOULASER CO2 with Wavelength 10.6μm and Laser Power 30W. The YOULASER CO2 Laser is composed externally of a metallic shell with a frontal polyurethane panel containing the touch screen display. On this panel the key switch, emergency red push button and the operation led are inserted too. On the rear panel the footswitch connector, the remote interlock, the power switch are located. The laser system is composed of power supply, CO2 laser source with air cooling system, optical bench, arm with CO2 scanner, the articulated control electronics. The electronic, based on a microcontroller, manages the voltage power supply and the CO2 laser source.

Nd:YAG (1064nm): The DUOLITE Q-Switched laser is intended for treatment of vascular lesions, pigmented lesions, and for hair removal and the incision, excision, ablation, vaporization of soft tissue for general dermatology. The DUOLITE Q-Switched laser is intended for tattoo removal (blue, black and green tattoo) Nd: YAG (532nm): The DUOLITE Q-Switched laser is intended for treatment of vascular lesions, pigmented lesions, and for hair removal and the incision, excision, ablation, vaporization of soft tissue for general dermatology. The DUOLITE Q-Switched laser is intended for tattoo removal (red, violet, orange, yellow and brown tattoo)

The device includes a Q-Switched Nd: YAG laser source with 900mJ max energy at 1064 nm and 450mJ max energy at 532 nm wavelengths. The optical delivery system for the two wavelengths is the articulated arm. In addition, the DUOLITE includes a power supply; a cooling system; an optical delivery system; a microprocessor based controller; and safety features to ensure use of the appropriate laser, wavelength and hand piece.

The Quanta System QUANTA Diode Laser Family, including the QUANTA532, QUANTA808, QUANTA940, QUANTA980, QUANTA1064, QUANTA1320, QUANTA1470, and QUANTA1950 (and all their double wavelength combination and their delivery accessories used to deliver optical energy) are indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology (BPH), Genitourinary (Urology), Thoracic Surgery, Plastic Surgery and Dermatology, Aesthetics including vascular lesions and hair removal, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery(PLDD), Gastroenterology, Head/neck/ENT and Radiology, Endovascular coagulation, Oral Surgery and Dental procedures. The QUANTA980 and QUANTA1470 Diode Laser are further indicated for laser assisted lipolysis.

The QUANTA Diode Laser Family is designed with 4 major subsystems: (1) an external structure; (2) power electronics; (3) display with control electronics, which controls the power electronics, the user interface and the laser source temperature via a thermostat board: and (4) the laser system with an opto-mechanical block composed of the laser source, the Peltier cooling system with dissipater and fans, the fiber launching system, the red diode aiming beam, and the power calibration system. The fiber is connected to the system through an SMA 905 socket on the front panel. In addition to the four subsystems, the QUANTA Diode Laser Family incorporates several safety features, including a remote interlock, an emergency red push button and a key switch. The external accessories include separate optical fibers and hand pieces for dental, dermatological and surgical applications, or for endovascular applications and laser assisted lipolysis.

The LITHO laser system and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotnpsy. Gasteroenterology, Arthroscopy, Discetomy Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery and General Surgery.

The LITHO Laser System is a surgical laser instrument for use in general surgery and dermatology. The LITHO Laser System includes 1 model. The LITHO laser system is designed with five major sub-systems, including: (1) Power Supply: a high voltage power supply, which converts and rectifies the AC mains current to provide regulated power for the flash lamp simmer current and main triggering pulse; (2) Cooling System: a cooling system consisting of an internal water flow circuit together with water-to-air heat exchanger; (3) Laser System: an Ho:YAG laser rod, capable of generating laser pulses at 2.1um wavelength and a frequency up to 20 Hz; (4) Delivery System: an optical delivery system, interfacing the energy from the laser to the patient via an optical fiber and focusing hand piece; (5) Display and Control Electronics: a display with control electronics, which regulates the functions of the laser and allows parameter selection by the user. In addition to the five subsystems, the LITHO laser system incorporates several safety features, including a remote interlock, an emergency red push button, a footswitch and a key switch.