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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 mm 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 or 580-950 nm. * Flow Mode is suitable for Fitzpatrick skin types I-VI. Recommended wavelength: 635nm-950mm.
• Treatment of Benign Pigmented Epidermal and Cutaneous Lesions including warts, scars and striae in all skin types (1-VI) to the Fitzpatrick scale - Recommended wavelength in the range of 580-950 mm.
• 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 & 860-1200mm.
• 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: Y AG 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-lat macules; Sebortheic; keratoses; Nevi and nevus of Ota, Chloasma; Verrucae; Skin tags; 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.
• 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 O-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 tattoos); * Tattoo removal: Light blue; Yellow; Red; Green. * Benign pigmented lesions, such as, but not limited to: Cafe-au-lat (macules); Lentigines (senile and solar); Freckles (ephelides); Chloasma; 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) for Skin resurfacing; Treatment of wrinkles; Epidermal nevi; Telangiectasia; Spider veins; Actinic chelitis; Keloids; Verrucae; Skin tags; Keratoses; Scar revision (including acne scars).

The Omnimax Device Series, which includes the Omnimax S3 and S4 devices, is a multiapplication, multi-technology platform designed for skin treatments and various aesthetic and dermatological applications. This is achieved by applying light energy (IPL, IR, and Laser) and Radio Frequency (RF) to the human skin. Each device in the series features the following technologies:

The Omnimax S4 incorporates IPL-DPC, IR, RF, and Laser technologies. The Omnimax S3 incorporates IPL-DPC, IR, and RF technologies.

The Omnimax Device Series modification enhances capabilities of the legally cleared Dermatological Treatment Device Family (K111303) by adding RF functionality with optional handpieces in addition to the previously cleared IPL, Laser and IR technology. The system consists of:

• a) Main unit (includes controller)
• b) Control Panel (UI)
• c) RF Module
• d) Display Unit
• e) Footswitch
• Trolley f)
• g) 14 Handpieces/applicators:
  • IPL-DPC 7 Handpieces ●
  • IR 2 Handpieces .
  • Laser 3 Handpieces ●
  • RF 2 Handpieces ●

The main unit is a platform system with embedded software, designed to support all treatment technologies and handpieces (i.e. IPL-DPC, IR, Laser and RF).

The provided text is a 510(k) summary for the Omnimax Device Series. This document focuses on demonstrating substantial equivalence to predicate devices rather than presenting the results of a specific clinical study with predefined acceptance criteria for a novel AI device. Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert adjudication, and MRMC studies is not available in this document.

However, I can extract and infer some information based on the provided text, particularly regarding the rationale for not conducting new clinical performance studies for certain aspects of the device.

Here's a summary of the available and inferred information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria for device performance. Instead, it relies on demonstrating substantial equivalence to existing predicate devices. The "performance" is considered equivalent if the technological characteristics (wavelengths, fluence/power, pulse width, spot size, repetition rate, target population, materials, coolant method, anatomical sites) are comparable to the predicate devices.

The table below summarizes the comparison of key technical characteristics, which serve as the basis for the equivalence claim:

2. Sample Size Used for the Test Set and Data Provenance:

No new clinical or performance test sets were explicitly detailed for the Omnimax Device Series to establish performance for this specific 510(k) submission. The regulatory strategy is based on demonstrating substantial equivalence to predicate devices, leveraging their established safety and efficacy profiles.

For the RF function, which is an added capability compared to one of its predicates, the document states: "the safety and efficacy of radiofrequency devices emitting energy with a frequency of 1 MHz and power of 50W is well established in scientific research and clinical studies. Multiple studies with these and similar systems have shown safety in dermatologic therapy and the devices were cleared by the FDA for therapy of wrinkles and rhytids." This indicates that the "test data" for the RF component is derived from existing scientific literature and previous FDA clearances for similar devices, rather than a new study specific to Omnimax. This is an indirect, retrospective approach drawing from existing public domain and regulatory data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

Not applicable in the context of this 510(k) submission as no new, primary clinical test set with ground truth established by experts was conducted for the Omnimax Device Series. The assessment hinges on the existing body of evidence supporting the predicate devices and general scientific knowledge for the added RF function.

4. Adjudication Method for the Test Set:

Not applicable.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

No. This document does not describe an MRMC study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable. The Omnimax Device Series is a physical medical device (laser/light/RF system), not an AI algorithm.

7. The Type of Ground Truth Used:

For the IPL, IR, and Laser technologies: The "ground truth" is effectively the established safety and efficacy of the predicate device (Dermatological Treatment Device Family K111303), supported by its prior FDA clearance based on its own clinical, performance, and safety data.

For the RF technology: The "ground truth" is a combination of:

• Literature-based evidence: "well established in scientific research and clinical studies."
• Regulatory history: "devices were cleared by the FDA for therapy of wrinkles and rhytids."
• Comparison to predicate: "power and frequency of the Omnimax Device Series are within the range of previously cleared values" from the Apollo System (K111026).

This relies on existing outcomes data and expert consensus over time, published in scientific literature and incorporated into previous regulatory clearances.

8. The Sample Size for the Training Set:

Not applicable, as this is not an AI/ML device requiring a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable.

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