510(k) · Cleared
ClearedRapid Family
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sharplight Technologies, Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Nov 20, 2017 after a 52-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Nov 20, 2017
- Review
- 52 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
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…
Read the full statement (720 words)
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 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 Q-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; Keratoses; Plaques
Rapid Family systems and optional Er:YAG 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; Anal 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
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K173169 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173169: Rapid Family.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173169
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026