510(k) · Cleared
ClearedDermatological Treatment Device 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 Dec 21, 2011 as substantially equivalent to K082876 (Sharplight Technologies, Ltd., 2008) and 3 other predicates after a 226-day review. Its family tree reaches back 16 generations to 1995. 56 later devices descend from it.
- Decided
- Dec 21, 2011
- Review
- 226 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 16 generations to K943450 (1995). 251 ancestors in all, the oldest K800617 (1980). 56 later devices descend from it, 7 citing it directly.
- Root · 16 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 12 generations between
- 3 generations backK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
- 2 generations backK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- 1 generation backK082876 Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd. · 2008
- This deviceK111303 Dermatological Treatment Device FamilySharplight Technologies, Ltd. · 2011
- Descendant · cites it directly · 33 of its ownK133837 Viora V-TotalViora, Ltd. · 2014
- Descendant · 2 generations on · 32 of its ownK142093 V20 SystemViora, Ltd. · 2014
- Descendant · 3 generations on · 31 of its ownK150035 V10 systemViora, Ltd. · 2015
- Descendant · 4 generations on · 18 of its ownK153568 InMode Plus SystemInmode MD, Ltd. · 2016
- Descendant · 5 generations on · 13 of its ownK172302 InMode PLUS SystemInmode MD, Ltd. · 2017
Show all 16 generations
- Root · 16 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 15 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 14 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 13 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 12 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 11 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 10 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 9 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 8 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 7 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 6 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 5 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 4 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 3 generations backK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
- 2 generations backK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- 1 generation backK082876 Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd. · 2008
- This deviceK111303 Dermatological Treatment Device FamilySharplight Technologies, Ltd. · 2011
Showing 5 of 56 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 56 · See all- K133837Viora V-TotalViora, Ltd. · 2014 · cites it directly33descendants
- K142093V20 SystemViora, Ltd. · 2014 · 2 generations on32descendants
- K150035V10 systemViora, Ltd. · 2015 · 3 generations on31descendants
- K153568InMode Plus SystemInmode MD, Ltd. · 2016 · 4 generations on18descendants
- K172302InMode PLUS SystemInmode MD, Ltd. · 2017 · 5 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −15 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −14 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −13 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −12 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −11 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −10 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −9 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −8 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −7 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −6 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −5 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −4 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −3 | K060448 | Lumenis One Family of Systems; Lumenis One. | Lumenis, Ltd. | 2006 | — |
| −2 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| −1 | K082876 | Beamax/ Formax Pulsed Light Device Family | Sharplight Technologies, Ltd. | 2008 | — |
| 0 (this device) | K111303 | Dermatological Treatment Device Family | Sharplight Technologies, Ltd. | 2011 | — |
| +1 | K133837 | Viora V-Total | Viora, Ltd. | 2014 | — |
| +2 | K142093 | V20 System | Viora, Ltd. | 2014 | — |
| +3 | K150035 | V10 system | Viora, Ltd. | 2015 | — |
| +4 | K153568 | InMode Plus System | Inmode MD, Ltd. | 2016 | — |
| +5 | K172302 | InMode PLUS System | Inmode MD, Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 6 | 0 |
| 1992 | 3 | 0 |
| 1993 | 8 | 0 |
| 1994 | 11 | 0 |
| 1995 | 13 | 0 |
| 1996 | 16 | 0 |
| 1997 | 21 | 0 |
| 1998 | 16 | 0 |
| 1999 | 10 | 0 |
| 2000 | 22 | 0 |
| 2001 | 24 | 0 |
| 2002 | 30 | 0 |
| 2003 | 21 | 0 |
| 2004 | 12 | 0 |
| 2005 | 9 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 6 | 0 |
| 2017 | 5 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 6 | 0 |
| 2021 | 4 | 0 |
| 2022 | 5 | 0 |
| 2023 | 3 | 0 |
| 2024 | 5 | 0 |
| 2025 | 7 | 0 |
| 2026 | 5 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K082876 | Beamax/ Formax Pulsed Light Device FamilySummary page 1…21 CFR § 878.4810 Regulatory Class: 11 Identification of Legally Marketed Predicate Devices SharpLight - BEAMAX/FORMAX Pulse Light device family - K082876 Alma lasers - Harmony XLT Multi -Application Platform - K072564 Cutera Optional Pulsed Light Hand Piece Family -… | 2008 |
| * | K072564 | Alma Lasers Harmony XL Multi-Application PlatformSummary page 1…ly Marketed Predicate Devices SharpLight - BEAMAX/FORMAX Pulse Light device family - K082876 Alma lasers - Harmony XLT Multi -Application Platform - K072564 Cutera Optional Pulsed Light Hand Piece Family - K050047 Palomar LuxiR Fractional Hand piece -… | 2008 |
| * | K050047 | Cutera Optional Pulsed Light Hand Piece FamilySummary page 1…e family - K082876 Alma lasers - Harmony XLT Multi -Application Platform - K072564 Cutera Optional Pulsed Light Hand Piece Family - K050047 Palomar LuxiR Fractional Hand piece - K060069 Device Description The Dermatologic Treatment System… | 2005 |
| * | K060069 | Palomar Luxir Fractional HandpieceSummary page 1…Platform - K072564 Cutera Optional Pulsed Light Hand Piece Family - K050047 Palomar LuxiR Fractional Hand piece - K060069 Device Description The Dermatologic Treatment Systems (DTS) device family and optional hand pieces, including Intensive Pulse… | 2006 |
What descends from it? (56)
See all 567 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
What does this lineage say?
- The line of descent spans 16 years and passes through 7 companies; a new generation was cleared every 9 months on median.
- 9 of the 251 ancestors have a recall of any class.
- Of its descendants, K133837 (Viora, Ltd., 2014) has gone furthest, with 33 descendants of its own.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
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 Dermatological Treatment device family and optional Hand pieces with 415 - 1200 nin wavelengths (with and without contact-cooling) are indicated for: * Hair removal and Permanent Hair Reduction in all skin types (I-VT) to the…
Read the full statement (713 words)
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 Dermatological Treatment device family and optional Hand pieces with 415 - 1200 nin wavelengths (with and without contact-cooling) are indicated for:
* Hair removal and Permanent Hair Reduction in all skin types (I-VT) to the Fitzpatrick scale - Recommended wavelengths in the range of 635-950 nm, 730-950 nm or 580-950rn
* Treatment of Pigmented and Vascular Lesions in all skin types (L-VI) to the Fitzpatrick scale - Recommended wavelength in the range of 535-950 n
* 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 (1-VT) to the Fitzpatrick scale - Recommended wavelength in the range of 580-950 nmn
*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-l200nm
The Dermatological Treatment device family and optional Infrared (IR) Hand Pieces with 850 - 1750 nm wavelengths (with contact cooling) is indicated for:
*Dermnatologic 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 (PEB)
The Dermatological Treatment device family and optional Nd:YAG Laser 1064 unm 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: Wadts; 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, Chlcasma; 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
Continued : The Dermatological Treatment device family and optional Nd:YAG Laser 1064 nm Long Pulse (LP) and Q-Switched Hand Pieces is 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 1-VI), including tanned skin.
The Dermatological Treatment device family and optional Nd:YAG Laser 532 nm Frequency Dabbler (FD) Long Pulse (LP) and Q-Switched Hand Pieces is indicated fo r:
" 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:VAG 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 resurfacing3 Treatment of wrinkles; Epidermal nevi; Telangiectasia; Spider veins; Actinic chelitis; Keloids; Verrucae; Skin tags; Anal tags; Keratoses; Scar revision (including acne scars);
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111303 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111303: Dermatological Treatment Device Family.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111303
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026