(226 days)
The Dermatological Treatment Systems device family and optional Hand Piece family are intended for use in aesthetic and cosmetic applications and in selective treatments required in the medical specialties of dermatology.
The DTS device family is indicated for dermatological treatments such as, but not limited to:
- Hair removal in all skin types to the Fitzpatrick scale. Permanent Hair Reduction.
- Treatment of Vascular Lesions
- Treatment of Inflammatory Acne (acne vulgaris)
- Treatment of Benign Pigmented Epidermal and Cutaneous Lesions including warts, scars and striae.
- Treatment of Wrinkles, rhytids and Periorbital Wrinkles
- Skin resurfacing (Acne scars)
- Treatment of Tattoos
- Treatment of Leg and Facial Vein Removal
- Treatment of photocoagulation of soft tissue in dermatologic applications
- Resurfacing of the skin, and for the treatment of facial wrinkles.
The Dermatological Treatment device family and optional Hand pieces with 415 -1200 nm wavelengths (with and without contact-cooling) are indicated for:
- Hair removal and Permanent Hair Reduction in all skin types (I-VI) to the Fitzpatrick scale - Recommended wavelengths in the range of 635-950 nm, 730-950 nm or 580-950 nm
- Treatment of Pigmented and Vascular Lesions in all skin types (I-VI) to the Fitzpatrick scale - Recommended wavelength in the range of 535-950 nm
- Treatment of Inflammatory Acne (acne vulgaris) in skin types (I-V) to the Fitzpatrick scale - Recommended wavelength in the range of 415-950 nm
- Treatment of Benign Pigmented Epidermal and Cutaneous Lesions including warts, scars and striae in all skin types (I-VI) to the Fitzpatrick scale - Recommended wavelength in the range of 580-950 nm
- Treatment of Benign Pigmented Epidermal, Cutaneous and Vascular Lesions including warts; scars and striae in skin types (I-V) to the Fitzpatrick scale - Recommended wavelength in the range of 535-680 nm & 860-1200nm
The Dermatological Treatment device family and optional Infrared (IR) Hand Pieces with 850 - 1750 nm wavelengths (with contact cooling) is indicated for:
- Dermatologic Treatment such as, but not limited to: photocoagulation of soft tissue (Scars, Wrinkles, Rhytids and Periorbital Wrinkles)
The Dermatological Treatment device family and optional Nd: YAG Laser 1064 nm Long Pulse (LP) Hand Pieces is indicated for:
- Removal of unwanted hair, for stable long-term, or permanent, hair reduction through selective targeting of melanin in hair follicles.
- Removal or lightening of unwanted hair (with and without adjuvant preparation)
- Treatment of pseudofolliculitis barbae (PFB)
The Dermatological Treatment device family and optional Nd:YAG Laser 1064 nm Long Pulse (LP) and Q-Switched Hand Pieces is indicated for:
- Benign vascular lesions such as, but not limited to treatment of: Port wine stains; Hemangiomas; Warts, Superficial and deep telangiectasias (venulectasias); Reticular veins (0.1-4.0 mm dia.) of the leg; Rosacea; Venus lake; Leg veins; Spider veins; Poikiloderma of Civatte; Angiomas
- Benign cutaneous lesions, such as, but not limited to: Warts; Scars; Striae; Psoriasis
- Benign pigmented lesions such as, but not limited to: Lentigos (age spots); Solar lentigos (sun spots); Cafe-au-lait macules; Seborrheic; keratoses; Nevi and nevus of Ota, Chloasma; Verrucae; Skin tags; Keratoses; The removal of black, blue or green tattoos (significant reduction in the intensity of black and /or blue/black tattoos); Plaques
- 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.
- The non-ablative treatment of facial wrinkles, such as, but not limited to: Periocular wrinkles; Perioral wrinkles
- Laser skin resurfacing procedures for the treatment of: Acne scars; Wrinkles
- Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
- Indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.
The Dermatological Treatment device family and optional Nd:YAG Laser 532 mm Frequency Dabbler (FD) Long Pulse (LP) and Q-Switched Hand Pieces is indicated for:
- Tattoo removal: Light blue; Yellow; Red; Green
- Vascular lesions: Hemangiomas (Port wine stains/birthmarks, cavernous, cherry, spider); hemangiomas; Angiomas (cherry, spider); Telangiectasia; Spider nevi
- Benign pigmented lesions, such as, but not limited to: Cafe-au-lait (macules); Lentigines (senile and solar); Freckles (ephelides); Chloasma; Nevi; Nevus spillus, Nevus of Ota: Becker's Nevi;
- Other pigmented cutaneous lesions, such as, but not limited to: Verrucae; Skin tags; Keratoses; Plaques
The Dermatological Treatment device family and optional Er:YAG Laser 2940 nm Long Pulse (LP) Hand Pieces, with standard and scanner accessory tips is indicated for:
Use in soft tissue (skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands) such as, but not limited to:
- Dermatology and plastic Surgery: Skin resurfacing; Treatment of wrinkles; Epidermal nevi; Telangiectasia; Spider veins; Actinic chelitis; Keloids; Verrucae; Skin tags; Anal tags; Keratoses; Scar revision (including acne scars);
The Dermatologic Treatment Systems (DTS) device family and optional hand pieces, including Intensive Pulse Light (IPL) Infrared light (IR) and Laser light technologies for dermatological treatments by delivery of energy to the human skin. The device family is a modification to the BeaMax/ ForMax family (K082876), pulsed light energy device based on a filtered, Xenon flashlamp.
The DTS device family modification enhances capabilities of the legally cleared Beamax/ Formax device family by adding new hand pieces that are now supporting Laser and IR technologies as well as the IPL technology.
The Basic unit is a platform system, designed to support all treatment technologies hand pieces (i.e. IPL, IR and Laser).
The embedded software is the heart of the control system which provides a control of all of the parameters to the relevant hand piece, where the operator has the access to modify some parameters via the touch screen and every hand piece has its own operating screen.
The provided text is a 510(k) summary for a medical device (K111303). It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, a detailed study proving the device meets specific acceptance criteria, as requested in your prompt, is not present in this document.
This 510(k) summary focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than providing a performance study with defined acceptance criteria and statistical analysis. The "Safety & Effectiveness" section states that "Based on the performance results provided (including test results and clinical data) and the analysis of similarities and differences presented above, SharpLight Technologies Ltd. believes that the proposed device family safe & effectiveness is substantially equivalent to the predicate devices without raising new safety and/or effectiveness issues." This implies that the performance data exists elsewhere (likely in the full 510(k) submission not fully provided here), but the summary itself does not detail specific acceptance criteria or the study that demonstrates compliance.
Therefore, I cannot populate the table or answer the specific questions about sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details because this information is not included in the provided text.
The information that is available related to this device's performance claim is:
- Claim of Substantial Equivalence: The manufacturer asserts that the device is substantially equivalent to predicate devices based on similarities in intended use, indications, technology, performance, and specifications.
- Wider Indications: The device family has "wider indications for use," enhancing its capability compared to predicate devices that support only partial treatments.
- General Performance Statement: The statement "Based on the performance results provided (including test results and clinical data)" indicates that some form of performance evaluation was conducted and submitted as part of the full 510(k) application, but the specifics are not detailed in this summary.
Conclusion: The provided 510(k) summary (K111303) does not contain the detailed acceptance criteria and the comprehensive study information required to answer your specific questions. The document focuses on demonstrating substantial equivalence rather than presenting a performance study with explicit acceptance metrics.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.