Rapid Family

Sharplight Technologies, Ltd.

Country / region:Israel (IL)Submission type:Special

Product code GEX· 21 CFR 878.4810

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Product code

GEX
21 CFR 878.4810

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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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