Manufacturer
Sharplight Technologies, Ltd.Rapid Family
Country / Region:Israel (IL)Submission type:Special
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Predicate devices
0
Cited in this 510(k)
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K173169
- Device name
- Rapid Family
- Country / Region
- Israel(IL)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2017-09-29
- Decision date
- 2017-11-20
- Submission type
- Special
- Technology type
- Other(AI inferred)
- Clinical applications
- Hair removal
- Primary application
- Hair removal
- Classification source
- AI classified
Indications for Use
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; 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 wrin
Intended Use
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; Treatment of Pigmented and Vascular Lesions in all skin types (I-VI) to the Fitzpatrick scale; Treatment of Inflammatory Acne (acne vulgaris) in skin types (I-V) to the Fitzpatrick scale; Treatment of Benign Pigmented Epidermal and Cutaneous Lesions including warts, scars and striae in all skin types (I-VI) to the Fitzpatrick scale; Treatment of Benign Pigmented Epidermal, Cutaneous and Vascular Lesions including warts; scars and striae in skin types (I-V) to the Fitzpatrick scale. 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; 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, benign cutaneous lesions, benign pigmented lesions, and the non-ablative treatment of facial 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 and wrinkles.
Summary parsed at:2026-06-01 06:01:11 UTC
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