(52 days)
Rapid Family systems and optional Hand-Pieces are intended for use in aesthetic and cosmetic applications and in selective treatments required in the medical specialties of dermatology.
Rapid Family systems and optional Hand-pieces with 420 – 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 420-950 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
Rapid Family systems and optional Infrared (IR) Hand Pieces with 850 - 1750 nm wavelengths (with contact cooling) are indicated for:
- Dermatologic Treatment such as, but not limited to: photocoagulation of soft tissue (Scars, Wrinkles, Rhytids and Periorbital Wrinkles)
Rapid Family systems and optional Nd: YAG Laser 1064 nm Long Pulse (LP) Hand-Pieces are 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)
Rapid Family systems and optional Nd:YAG Laser 1064 nm Long Pulse (LP) and Q-Switched Hand-Pieces are 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; Sebortheic; 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 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
Rapid Family systems and optional Nd:YAG Laser 1064 nm Long Pulse (LP) and Q-Switched Hand-Pieces are indicated for:
- 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.
Rapid Family systems and optional Nd: YAG Laser 532 nm Frequency Dabbler (FD) Long Pulse (LP) and O-Switched Hand-Pieces are 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; Plaques
Rapid Family systems and optional Er: Y AG Laser 2940 nm Long Pulse (LP) Hand-Pieces, with standard and scanner accessory tips are 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: Keratoses: Scar revision (including acne scars)
NOTE Permanent hair reduction is defined as the long-term stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regimen
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The provided text is a 510(k) premarket notification letter from the FDA regarding the "Rapid Family" device. This document primarily outlines the regulatory approval for the device and lists its Indications for Use. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot provide the requested information based on the input text. The document focuses on regulatory equivalence and intended uses rather than detailed performance study results.
§ 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.