510(k) · Cleared
ClearedOmnimax S3, Omnimax S4
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 22, 2023 as substantially equivalent to K111303 (Sharplight Technologies, Ltd., 2011) and 1 other predicate after an 84-day review. Its family tree reaches back 17 generations to 1995.
- Decided
- Dec 22, 2023
- Review
- 84 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 17 generations to K943450 (1995). 257 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 17 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 13 generations between
- 3 generations backK083461 Imagine TC Skin Therapy SystemEndymion Medical, Ltd. · 2009
- 2 generations backK100586 Venus Freeze SystemVenus Concept, Ltd. · 2010
- 1 generation backK111026 ApolloPollogen, Ltd. · 2011
- This deviceK233304 Omnimax S3, Omnimax S4Sharplight Technologies, Ltd. · 2023
Show all 17 generations
- Root · 17 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 16 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 15 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 14 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 13 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 12 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 11 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 10 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 9 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 8 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 7 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 6 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 5 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 4 generations backK070004 AccentAlma Lasers, Ltd. · 2007
- 3 generations backK083461 Imagine TC Skin Therapy SystemEndymion Medical, Ltd. · 2009
- 2 generations backK100586 Venus Freeze SystemVenus Concept, Ltd. · 2010
- 1 generation backK111026 ApolloPollogen, Ltd. · 2011
- This deviceK233304 Omnimax S3, Omnimax S4Sharplight Technologies, Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −16 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −15 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −14 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −13 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −12 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −11 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −10 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −9 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −8 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −7 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −6 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −5 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −4 | K070004 | Accent | Alma Lasers, Ltd. | 2007 | — |
| −3 | K083461 | Imagine TC Skin Therapy System | Endymion Medical, Ltd. | 2009 | — |
| −2 | K100586 | Venus Freeze System | Venus Concept, Ltd. | 2010 | — |
| −1 | K111026 | Apollo | Pollogen, Ltd. | 2011 | — |
| 0 (this device) | K233304 | Omnimax S3, Omnimax S4 | Sharplight Technologies, Ltd. | 2023 | — |
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 | 10 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2011 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K111303 | Dermatological Treatment Device FamilySummary page 6…Surgery and Dermatology Identification of Legally Marketed Predicate Devices SharpLight – Dermatological Treatment Device Family K111303 Pollogen – Apollo System K111026… | 2011 |
| * | K111026 | ApolloSummary page 6…ally Marketed Predicate Devices SharpLight – Dermatological Treatment Device Family K111303 Pollogen – Apollo System K111026 Page 1 of 11 SharpLi… | 2011 |
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.
What does this lineage say?
- The line of descent spans 28 years and passes through 9 companies; a new generation was cleared every 12 months on median.
- 9 of the 257 ancestors have a recall of any class.
- 6 other devices also cite its predicate K111303.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Omnimax Device Series along with its optional Handpieces, uses IPL, IR, Laser and RF technologies and is intended for use in aesthetic and cosmetic applications and in selective treatments in medical specialties of dermatology, through the transmission of energy to human skin. Intense Pulsed Light (IPL-DPC) with 415 – 1200 nm wavelengths (with and without contact-cooling) handpieces are indicated for: * Hair removal and Permanent Hair Reduction in…
Read the full statement (632 words)
The Omnimax Device Series along with its optional Handpieces, uses IPL, IR, Laser and RF technologies and is intended for use in aesthetic and cosmetic applications and in selective treatments in medical specialties of dermatology, through the transmission of energy to human skin.
Intense Pulsed Light (IPL-DPC) with 415 – 1200 nm wavelengths (with and without contact-cooling) handpieces are indicated for:
* Hair removal and Permanent Hair Reduction in all skin types (I-V) to the Fitzpatrick scale - Recommended wavelengths in the range of 635-950 nm, 730-950 nm or 580-950 nm. * Flow Mode is suitable for Fitzpatrick skin types I-VI. Recommended wavelength: 635nm-950nm.
* 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 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 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.
* Treatment of Inflammatory Acne (acne vulgaris) in skin types (I-V) to the Fitzpatrick scale – Recommended wavelength in the range of 415-950 nm.
Infrared (IR) with 850 – 1750 nm wavelengths (with contact cooling) handpieces is indicated for:
* Dermatologic Treatment such as, but not limited to: photocoagulation of soft tissue (Scars, Wrinkles, Rhytids and Periorbital Wrinkles).
Radio Frequency (RF) handpieces are indicated for:
* Treatment of mild to moderate facial wrinkles and rhytids for all skin types.
Nd:YAG Laser 1064 nm Long Pulse (LP) handpiece 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.
* Treatment of pseudofolliculitis barbae (PFB).
* 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; 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.
* 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).
Nd:YAG 1064 nm Q-Switched Laser with optional 532 nm Frequency Doubler (FD) handpiece indicated for:
* The removal of black, blue or green tattoos (significant reduction in the intensity of black and /or blue/black tattoos);
* Tattoo removal: Light blue; Yellow; Red; Green. * 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.
Er:YAG Laser 2940 nm Long Pulse (LP), with standard and scanner accessory tips handpiece is indicated for:
* Use in soft tissue (skin, cutaneous tissue, subcutaneous tissue) for Skin resurfacing; 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/K233304 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233304: Omnimax S3, Omnimax S4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233304
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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