Search Results

Chrome is intended for use in aesthetic, cosmetic and surgical applications requiring incision, ablation, vaporization and coagulation of body soft tissues in the medical specialties of dermatology, general, plastic and oral surgery as follows.

Indications for use

1064 & 532 nm (Q-Switched, nanosecond mode)

Chrome is intended for treatment of benign vascular lesions, benign pigmented lesions, and for hair, tattoo removal and the incision, excision, ablation, vaporization of soft tissue for General dermatology such as, but not limited to treatment of:

532 nm (Q-Switched, nanosecond mode), including microbeam handpieces: Removal of light ink (red, sky blue, green, tan, purple, and orange) tattoos

Treatment of benign vascular lesions including, but not limited to:

• port wine birthmarks
• telangiectasias
• spider angioma
• Cherry angioma
• Spider nevi

Treatment of benign pigmented lesions including, but not limited to:

• cafe-au-Iait birthmarks
• Ephalides, solar lentigines
• senile lentigines
• Becker's nevi
• freckles
• common nevi
• nevus spilus
• Ota Nevus

Treatment of seborrheic keratosis

Treatment of post inflammatory hyperpigmentation

Skin resurfacing procedures for the treatment of acne scars and wrinkles.

1064 nm (Q-Switched, nanosecond mode), including microbeam handpieces: Removal of dark ink (black, blue and brown) tattoos

Removal of benign pigmented lesions including;

• nevus of Ota
• Café au lait spot
• Ephalides, solar lentigo (lentigines)
• Becker Nevus
• Nevus spilus

Treatment of common nevi

Removal or lightening of unwanted hair

Skin resurfacing procedures for the treatment of acne scars and wrinkles

1064 nm (pulsed)

Dermatology/Plastic Surgery:

Intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangectasia, rosacea, venus lake, leg veins and poikiloderma of civatte; and treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis.

The laser is also intended for the treatment of benign pigmented lessons such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, sebortheic keratoses, nevi, chloasma, verrucae, skin tags, keratosis and plaques.

The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. The laser is also indicated for the treatment of facial wrinkles.

Additionally, the laser is indicated for the treatment of pseudofolliculitis barbae (PFB) and for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

It is indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.

The laser is also indicated for benign pigmented lesion size, for patients with benign lesions that would potentiallybenefit from aggressive treatment, and for patients with benign that have not responded to other laser treatments.

It is indicated for use on all skin types (Fitzpatrick I-VI) including tanned skin, and the removal and permanent reduction of unwanted hair in Fitzpatrick I-VI, including suntanned skin types.

IPL 590-1200nm; 625-1200nm; 650-1200nm

Indicated for permanent hair removal.

Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime

IPL 550-1200nm; 570-1200nm

Indicated for photocoagulation of dermatological benign vascular lesion (i.e. face telangiectasia), photothermolysis of blood vessels (treatment of facial and leg veins), and treatment of benign pigmented lesions.

IPL 400-1200nm

Indicated for inflammatory acne (mild to moderate acne vulgaris).

Integrated Skin Cooler

The intended use of the integrated cooling system in the laser hand piece is to provide cooling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluencies for laser treatments such as hair removal and benign vascular lesion, and to reduce the potential side effects of laser treatments. Any other different use is considered incorrect.

Chrome is a laser family that includes Q-Switched and/or Pulsed laser sources, emitting at 532 nm and 1064 nm (Nd:YAG laser).

Chrome, through the special universal Twain connector, can be equipped with intense pulsed light handpieces (Twain IPL) emitting at the following wavelengths: 650-1200nm, 625-1200nm, 590-1200nm, 570-1200nm, 550-1200nm, 400-1200nm.

It can also be connected to Er:YAG handpieces cleared under K173002.

Chrome, when operating with Pulsed laser sources and IPL, can be used in combination with optional contact, or air, cooling systems.

The optical delivery system is an articulated arm with fixed or variable handpieces. The optical delivery system for the IPL system is a handpiece (Twain IPL) with fixed or interchangeable light filters at different wavelengths.

Chrome is controlled via a touch screen display housed in the front of the device.

Emission is triggered by means of a footswitch.

Here's an analysis of the provided text regarding the acceptance criteria and study proving device performance:

Unfortunately, the provided text does not contain information about acceptance criteria for performance, device performance metrics, or any clinical study details (sample size, data provenance, expert qualifications, adjudication, MRMC studies, standalone performance, or training set details).

The document focuses on regulatory approval (510(k) premarket notification) for a laser device called "Chrome." It establishes "substantial equivalence" to predicate devices, primarily based on technological characteristics and safety standards.

The sections that might typically contain such information (like "Performance data" and "Technological Characteristics Comparison") focus on:

• Performance data: Lists recognized consensus safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1) and states that "Software Verification and Validation Testing" was conducted. It also mentions biocompatibility was established by comparison to a predicate. This refers to safety and electrical performance standards, not clinical efficacy or diagnostic accuracy.
• Technological Characteristics Comparison: Compares specific technical parameters (laser wavelengths, pulse width, max fluence, spot size, repetition rate, microbeam handpiece details, IPL wavelengths) of the Chrome device to two predicate devices. This demonstrates that the device operates within similar technical specifications as already approved devices, not that it has met specific clinical performance criteria.

Therefore, I cannot populate the requested table and answer the detailed questions about the study that proves the device meets acceptance criteria, as that information is not present in the provided document.

The document primarily demonstrates:

1. Indications for Use: What conditions the device is intended to treat (various dermatological conditions, tattoo removal, hair reduction, etc.).
2. Technological Equivalence: That its technical specifications (laser types, wavelengths, power, etc.) are comparable to previously cleared devices.
3. Safety & Standards Compliance: That it complies with general safety and electrical standards for medical devices and lasers.

This type of 510(k) submission often does not require new clinical studies if substantial equivalence can be established based on technological characteristics and intended use compared to legally marketed predicate devices.

Ask a specific question about this device

The THUNDER Family is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization and coagulation of body soft tissues in the medical specialties of dermatology, general, plastic and oral surgery as follows.

1064 nm (pulsed)
Dermatology/Plastic Surgery:
Intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis.
The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratosis and plaques.
The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.
The laser is also indicated for the treatment of facial wrinkles.
Additionally, the laser is indicated for the treatment of pseudofolliculitis barbae (PFB) and for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months affer the completion of a treatment regime.
It is indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
The laser is also indicated for 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.
It is indicated for use on all skin types (Fitzpatrick I-VI ) including tanned skin, and the removal and permanent reduction of unwanted hair in Fitzpatrick I-VI, including suntanned skin types.

755 nm (pulsed)
Indicated for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing when measured 6, 9, or 12 months after the completion of a treatment regime. It is used for all skin types (Fitzpatrick I-VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles.

Skin Cooler
The intended use of the integrated cooling system in the Thunder family is to provide cooling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluences for laser treatments such as hair removal and vascular lesion, and to reduce the potential side effects of laser treatments.

This Special 510(k) of the modified device Thunder family is submitted due to Device Modifications of the already cleared device EVO family (K160368) due to hardware and software change, together with a broadening of the range of some laser emission parameters.

This document details a 510(k) premarket notification for the "Thunder" family of laser devices, focusing on modifications made to an already cleared device, the "EVO family" (K160368). The submission aims to demonstrate substantial equivalence to the predicate device despite hardware and software changes and a broadening of laser emission parameters.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states: "There are no mandatory performance standards for this device." This implies that specific quantitative acceptance criteria in terms of device accuracy, sensitivity, or specificity (as one might find for diagnostic AI models) are not applicable or provided within this submission.

Instead, the acceptance criteria are framed in terms of compliance with established safety and performance standards for medical electrical equipment and laser products. The reported "performance" is that the modified device "successfully passed" these tests.

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

No information is provided regarding a "test set" in the context of clinical data or patient samples. The testing described is against engineering and safety standards, not a clinical dataset. Therefore, there is no mention of sample size for a test set or data provenance (e.g., country of origin, retrospective/prospective). This device is a laser system for surgical/dermatological applications, not a diagnostic AI device requiring clinical ground truth for validation.

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

Not applicable. The "ground truth" for this device revolves around its compliance with safety and performance engineering standards, not medical diagnoses. Therefore, there's no mention of experts establishing a clinical ground truth for a test set.

4. Adjudication Method for the Test Set:

Not applicable, as there is no clinical test set requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

Not applicable. This device is a laser system for treatment, not a diagnostic tool that assists human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable in the typical sense of an AI algorithm. The device, as a laser system, operates "standalone" in that its hardware and software functions are tested independently of a human operator making a diagnostic decision. However, its intended use is always with a human operator. The performance testing focuses on the device's adherence to engineering specifications and safety standards as an independent unit.

7. The Type of Ground Truth Used:

The ground truth used for this device is compliance with established international and harmonized engineering and safety standards (e.g., IEC 60601 series, IEC 60825-1). This is a technical "ground truth" as opposed to a clinical or pathological ground truth:

• Safety Standards: Adherence to defined limits for electrical safety, EMI/EMC, laser output, etc.
• Performance Standards: The device meets its specified technical parameters (e.g., laser wavelength, power, pulse duration) within acceptable tolerances, which is evaluated during performance testing.
• Usability Standards: The device's user interface and operational aspects meet usability requirements.

8. The Sample Size for the Training Set:

Not applicable. This is a physical device (laser system), not an AI model trained on a dataset. There is no concept of a "training set" for the device itself or its modifications as described in this 510(k) summary.

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

Not applicable, as there is no training set for this type of device.

Ask a specific question about this device