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The Light Age Inc. EpiCare-YAG™ Laser System is intended for use in general and plastic surgery, dermatology, and podiatry for the treatment of vascular lesions, benign pigmented lesions, for the removal of dark tattoo inks and reduction of hypertrophic and keloid scars and for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hair regrowth after a treatment regime on all skin types (Fitzpatrick I-VI including tanned skin.) No new indications were sought in this 510(k) and no clinical data is presented. Specifically the 1064 nm wavelength is indicated for: - Removal of unwanted hair, for stable long term or permanent hair reduction on all skin types Fitzpatrick I-VI including tanned skin. - Photocoagulation and hemostasis of pigmented and vascular lesions such as but not limited to port wine stains, hemangioma, warts, telangiectasia, rosacea, venus lake, leg veins, and spider veins and poikiloderma of civatte. Coagulation and hemostasis of soft tissue. - Benign cutaneous lesions such as warts, scars, striae, and psoriasis - Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques. - Pigmented lesion size reduction in patients with lesions who would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. - Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar - Treatment of pseudofolliculitis barbae (PFB). - Treatment of wrinkles including but not limited to periocular wrinkles and perioral wrinkles.

The Light Age Inc. EpiCare-YAG™ Laser System is a Class IV laser surgical instrument for use in general medical / cosmetic procedures, general and plastic surgery and dermatology. Using neodymium YAG crystal rods, pulsed energy is emitted at 1064 nanometers in the near infrared portion of the spectrum under the guidance of a visible aiming beam. The device consists of the following components and accessories: - 1. Laser source and onboard microprocessor based control unit - 2. Laptop user interface - 3. Flexible optical fiber and handpiece delivers energy from the laser to the target area via optical fiber with handpiece, which produces a circular beam on the skin. - 4. Foot pedal switch activates delivery when lasers are enabled.

The Light Age, Inc. Q-Clear™ Nd:YAG Laser System is intended for use in general and plastic surgery, dermatology, and podiatry for the incision, excision, vaporization of soft tissues. The Light Age, Inc. Q-Clear™ Nd: YAG Laser is indicated for the following uses: The 1064nm wavelength is indicated for : 1. Podiatry for incision, excision, vaporization, coagulation of soft tissues including: - Matrixectomy - Warts including periungual, subungual, and plantar warts - Radical nail excision - Neuromas - The O-Clear™ Laser System is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.) 2. Dermatology and Plastic Surgery for incision, excision, vaporization, coagulation of soft tissues including: - Lesions of the skin and subcutancous tissue - Spider veins - Plantar Warts - Periungual and subungual warts - Debridement of decubitus ulcer - Treatment of keloids 3. General Dermatology - Dark ink tattoo removal - Treatment of pigmented lesions (particularly Nevus of Ota) - Removal or lightening of hair - Skin resurfacing with or without adjuvant preparation - Treatment of common Nevi The 532 nm wavelength is indicated for: 1. Dermatology and Plastic Surgery for incision, excision, vaporization, coagulation of soft tissues including spider veins: 2. General Dermatology - Removal of light ink (red, tan, purple, and orange) tattoos - Treatment of common nevi - Treatment of café-au-lait spots - Treatment of seborrheic keratoses Treatment of vascular lesions, including facial and leg veins, telangiectasias, angiomas, hemangiomas, port wine stains, and most pigmented lesions (e.g. lentigines, and ephelides)

The Light Age Q-Clear™ laser has an Nd:YAG crystal rod as a lasing medium. Pulsed energy is emitted at 1064 nanometers in the infrared portion of the spectrum. With the frequency doubler installed, a 532nm beam is emitted. The 532nm emission is visible green light. Energy from the laser is delivered directly to the target area via the handpiece, which produces a circular beam on the skin. A red aiming beam is provided to allow the operator to precisely target the treatment area. The Q-Clear™ Laser is equipped with safety fealures in conformance with 21 CFR Part 1040. The Q-Clear™ Nd:YAG laser system is comprised of the following main components: - (1) Main Console consists of electrical components including - a. Control and Display Panel with - Keyswitch controlling access to the system and mode of operation (off, standby and ready) - Emergency Stop Button - Remote Interlock Connector - Footswitch connector - Power Cord connector - (2) Footswitch - (3) Medical grade power cord - (4) Q-Switched 1064 / 532 nm Treatment Head with Nd:YAG laser rod - (5) Long Pulsed 1064 nm Treatment Head with Nd:YAG laser rod - (6) Delivery Devices intended for Non-Contact and contact with intact skin / tissue - a. Handpieces - b. Handbiece tips - (7) Operator and Patient safety glasses and goggles - (8) Accessories standoffs, water bottle

The Light Age, Inc. EpiCare-DUO™ Laser System is intended for use in general and plastic surgery, dermatology, and podiatry for the treatment of vascular lesions, benign pigmented lesions, for removal of dark tattoo inks and reduction of hypertrophic and keloid scars and for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hair regrowth after a treatment regime on all skin types (Fitzpatrick I-VI including tanned skin.) No new indications were sought in this 510(K) and no clinical data is presented. Light Age, Inc. is providing more specialized indications which are a subset of the previously cleared indications. From both a design and clinical perspective, the predicate and candidate laser devices, are of the same technology and have the same intended use. Based upon an analysis of the overall performance characteristics for the devices, Light Age, Inc. believes that no significant differences exist. 755nm - Specifically the 755 nm mode is indicated - Hair removal, and stable long-term or permanent hair reduction through selective targeting of melanin in hair follicles on all skin types (Fitzpatrick I-VI) including tanned skin. Permanent hair reduction is defined as long-term stable reduction in the number of hair regrowth after a treatment regime. The number of hairs re-growing must be stable over a time greater than the duration of the complete growth cycle of hair follicies, which varies from 4-12 months according to body location. Permanent hair reduction does not necessarily imply the elimination of all hairs in the treated area. - Treatment of vascular lesions - Treatment of benign pigmented lesions. - Treatment of wrinkles. 1064nm - - Removal of unwanted hair, for stable long term or permanent hair reduction on all skin types Fitzpatrick I-VI including tanned skin. - Photocoagulation and hemostasis of pigmented and vascular lesions, such as but not limited to port wine stains, hemoangioma, warts, telangiectasia, rosacea, venus lake, leg veins, and spider veins and poikiloderma of civatte. Coagulation and hemostasis of soft tissue. - Benign cutaneous lesions such as warts, scars striac and psoriasis. - Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheio keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plagues. - Pigmented lesion size reduction in patients with lesions who would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. - Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. - Treatment of pseudofolliculitis barbae (PFB). - Treatment of wrinkles including but not limited periocular wrinkles and perioral wrinkles, No new indications were sought in this premarket notification and no clinical data is presented. Light Age, Inc. is providing more specialized indications which are a subset of the previously cleared indications. From both a design and clinical perspective the predicate and candidate laser devices, are of the same technology and have the same intended use. Based upon an analysis of the overall performance characteristics for the devices, Light Age, Inc. believes that no significant differences exist.

The Light Age EpiCare-DUO™ Laser is a Class IV Laser Surgical Instrument for use in General medical/cosmetic procedures, General and Plastic surgery, Podiatry, and Dermatology. Using alexandrite and neodymium (Nd) YAG crystal rods, pused energy is emitted at 755 and 1064 nanometers in the near infrared portion of the spectrum under the guidance of a visible aiming beam. The device consists of the fploving components and accessories: 1. Laser Source and Onboard Microprocessor Based Control unit 2. Laptop User Interface 3. Flexible Optical Fiber and handpiece delivers energy from the laser to the target area via optical fiber with handpiece, which produces a circular bearn on the skin. 4. Foot Pedal Switch activates delivery when lasers are enabled.

The Light Age EpiCare™ Alexandrite Laser is 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 after 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.

The Light Age EpiCare™ Alexandrite Laser has an Alexandrite crystal rod as a lasing medium. Pulsed energy is emitted at 755 nanometers in the near infrared portion of the spectrum. Energy from the laser is delivered to the target area via optical fiber with handpiece, which produces a circular beam on the skin. The EpiCare™ Alexandrite Laser is equipped with safety interlocks to protect patients and operators.

The Light Age Q-Clear™ Laser is indicated for the following uses: 1. For incision, excision, ablation, and vaporization of soft tissue for General Dermatology 2. The 1064nm wavelength is indicated for: - Dark ink tattoo removal - Removal of pigmented lesions (particularly Nevus of Ota) - Removal or lightening of hair - Skin resurfacing with or without adjuvant preparation - Treatment of common nevi 3. The 532nm wavelength is indicated for: - Removal of light ink (red, tan, purple and orange) tattoos - Treatment of common nevi - Treatment of café-au-lait spots - Treatment of seborrheic keratoses - Treatment of vascular lesions, including facial and leg veins, telangiectasias, angiomas, hemangiomas, port wine stains, and most pigmented lesions (e.g. lentigines, and ephelides)

The Light Age Q-Clear™ Laser has a Nd: Y AG crystal rod as a lasing medium. Pulsed energy is emitted at 1064 nanometers in the near-infrared portion of the spectrum. With the optional frequency doubler installed, a 532nm beam is emitted. The laser is delivered directly to the target area via the handpiece, which produces a circular beam on the skin. A red aiming beam is provided to allow the operator to precisely target the treatment area. The Q-Clear™ Laser is equipped with safety features in conformance with 21CFR Part 1040.

The Light Age EpiCare™ Alexandrite Laser is intended for use in dermatology for the removal of dark, unwanted body hair.

The Light Age EpiCare™ Alexandrite Laser is a medical device capable of emitting an invisible pulsed treatment laser beam with a wavelength of 755 mm under the guidance of a visible aiming beam. This laser can be utilized in either a continuous or timed-exposure mode of operation.

Removal of dark and light ink tattoos and the removal of pigmented lesions.

The Alex Ta2 Eraser is a flashlamp Q-switched solid state laser producing a broadband wavelength of 755 ±25nm.