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The Light Age Inc. EpiCare-YAG™ Laser System is intended for use in general and plastic surgery, dermatology, and podiatry for the treatment of vascular lesions, benign pigmented lesions, for the removal of dark tattoo inks and reduction of hypertrophic and keloid scars and for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hair regrowth after a treatment regime on all skin types (Fitzpatrick I-VI including tanned skin.) No new indications were sought in this 510(k) and no clinical data is presented.

Specifically the 1064 nm wavelength is indicated for:

• Removal of unwanted hair, for stable long term or permanent hair reduction on all skin types Fitzpatrick I-VI including tanned skin.
• Photocoagulation and hemostasis of pigmented and vascular lesions such as but not limited to port wine stains, hemangioma, warts, telangiectasia, rosacea, venus lake, leg veins, and spider veins and poikiloderma of civatte. Coagulation and hemostasis of soft tissue.
• Benign cutaneous lesions such as warts, scars, striae, and psoriasis
• Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques.
• Pigmented lesion size reduction in patients with lesions who would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
• Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar
• Treatment of pseudofolliculitis barbae (PFB).
• Treatment of wrinkles including but not limited to periocular wrinkles and perioral wrinkles.

The Light Age Inc. EpiCare-YAG™ Laser System is a Class IV laser surgical instrument for use in general medical / cosmetic procedures, general and plastic surgery and dermatology. Using neodymium YAG crystal rods, pulsed energy is emitted at 1064 nanometers in the near infrared portion of the spectrum under the guidance of a visible aiming beam. The device consists of the following components and accessories:

• 1. Laser source and onboard microprocessor based control unit
• 2. Laptop user interface
• 3. Flexible optical fiber and handpiece delivers energy from the laser to the target area via optical fiber with handpiece, which produces a circular beam on the skin.
• 4. Foot pedal switch activates delivery when lasers are enabled.

The provided text describes a laser system, the EpiCare-YAG™ Laser System (K113117), which is a modified version of a previously approved device, the EpiCare-DUO™ Laser System (K091625). The submission is for a design change where the Alexandrite 755nm modules were removed, resulting in a device that operates only at the 1064nm wavelength.

This is a 510(k) Premarket Notification whose primary purpose is to demonstrate substantial equivalence to predicate devices, rather than a clinical study evaluating the performance of a new, unproven device against specific acceptance criteria in a clinical setting.

Therefore, the structure of the provided information does not contain the typical elements of a clinical study that would establish specific performance metrics and acceptance criteria for a novel device. Instead, the "acceptance criteria" here relate to regulatory compliance and the demonstration of substantial equivalence.

Here's an interpretation based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this 510(k) submission are implicitly tied to demonstrating that the modified device is as safe and effective as its predicate devices, and that it conforms to relevant standards. Since no new clinical indications were sought, no new clinical data or specific performance metrics are presented in the traditional sense for a clinical trial.

Regarding the specific questions about a "study":

The provided text does not describe a clinical study in the way one would for a novel device proving clinical acceptance criteria. Instead, it describes a regulatory submission (510(k)) based on substantial equivalence. Therefore, many of the requested details about a study are not applicable or extractable from this document.

1. Sample size used for the test set and data provenance: Not applicable. No specific "test set" in the context of a performance study is mentioned. The submission relies on prior clinical experience with the predicate device family ("over 1 million treatments performed" with the EpiCare™ product family over "nearly one decade," although this isn't a "test set" for this device's performance).
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No specific "ground truth" establishment by experts for a test set is described.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a laser surgical instrument, not an AI-assisted diagnostic device with "human readers."
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the device's acceptable performance is implied by the long-standing safe and effective use of the predicate device (EpiCare-DUO™) and its technology, and its conformity to established standards. No new clinical ground truth was established for this specific 510(k).
7. The sample size for the training set: Not applicable. No "training set" in the context of an algorithm or new device performance study is mentioned.
8. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) application is a regulatory pathway for modifications to existing devices, asserting that the modified device is substantially equivalent to a legally marketed predicate device. It does not involve new clinical trials or the establishment of new performance-based acceptance criteria through an independent study for the EpiCare-YAG™ system. The "study" here is essentially the demonstration of regulatory compliance and the logical argument for substantial equivalence based on the predicate device's established safety and effectiveness.

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The Light Age, Inc. Q-Clear™ Nd:YAG Laser System is intended for use in general and plastic surgery, dermatology, and podiatry for the incision, excision, vaporization of soft tissues. The Light Age, Inc. Q-Clear™ Nd: YAG Laser is indicated for the following uses:

The 1064nm wavelength is indicated for :

1. Podiatry for incision, excision, vaporization, coagulation of soft tissues including:

• Matrixectomy
• Warts including periungual, subungual, and plantar warts
• Radical nail excision
• Neuromas
• The O-Clear™ Laser System is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.)

2. Dermatology and Plastic Surgery for incision, excision, vaporization, coagulation of soft tissues including:

• Lesions of the skin and subcutancous tissue
• Spider veins
• Plantar Warts
• Periungual and subungual warts
• Debridement of decubitus ulcer
• Treatment of keloids

3. General Dermatology

• Dark ink tattoo removal
• Treatment of pigmented lesions (particularly Nevus of Ota)
• Removal or lightening of hair
• Skin resurfacing with or without adjuvant preparation
• Treatment of common Nevi

The 532 nm wavelength is indicated for:

1. Dermatology and Plastic Surgery for incision, excision, vaporization, coagulation of soft tissues including spider veins:
2. General Dermatology

• Removal of light ink (red, tan, purple, and orange) tattoos
• Treatment of common nevi
• Treatment of café-au-lait spots
• Treatment of seborrheic keratoses
  Treatment of vascular lesions, including facial and leg veins, telangiectasias, angiomas, hemangiomas, port wine stains, and most pigmented lesions (e.g. lentigines, and ephelides)

The Light Age Q-Clear™ laser has an Nd:YAG crystal rod as a lasing medium. Pulsed energy is emitted at 1064 nanometers in the infrared portion of the spectrum. With the frequency doubler installed, a 532nm beam is emitted. The 532nm emission is visible green light. Energy from the laser is delivered directly to the target area via the handpiece, which produces a circular beam on the skin. A red aiming beam is provided to allow the operator to precisely target the treatment area. The Q-Clear™ Laser is equipped with safety fealures in conformance with 21 CFR Part 1040.

The Q-Clear™ Nd:YAG laser system is comprised of the following main components:

• (1) Main Console consists of electrical components including
• a. Control and Display Panel with
• Keyswitch controlling access to the system and mode of operation (off, standby and ready)
• Emergency Stop Button
• Remote Interlock Connector
• Footswitch connector
• Power Cord connector
• (2) Footswitch
• (3) Medical grade power cord
• (4) Q-Switched 1064 / 532 nm Treatment Head with Nd:YAG laser rod
• (5) Long Pulsed 1064 nm Treatment Head with Nd:YAG laser rod
• (6) Delivery Devices intended for Non-Contact and contact with intact skin / tissue
• a. Handpieces
• b. Handbiece tips
• (7) Operator and Patient safety glasses and goggles
• (8) Accessories standoffs, water bottle

Here's an analysis of the provided text regarding the Light Age Q-Clear™ Nd:YAG Laser, focusing on acceptance criteria and the supporting study:

Acceptance Criteria and Reported Device Performance

The document describes the device's technical specifications and a clinical study related to a specific indication. The primary "acceptance criteria" presented here are through a comparative analysis with predicate devices for technical characteristics and through clinical study results for a specific indication.

Table 1: Acceptance Criteria (Technical Characteristics) and Reported Device Performance (as compared to predicates)

Table 2: Acceptance Criteria (Clinical) and Reported Device Performance

Study Details

The provided text details one specific clinical study related to the onychomycosis indication.

1. Sample size used for the test set and the data provenance:

   • Sample Size: 100 randomized subjects.
   • Data Provenance: Not explicitly stated, but the study design suggests a prospective clinical trial. The countries of origin are not mentioned, but the inclusion of "Caucasian, Asian, African American, and Latino" suggests a diverse population, possibly within the USA where the company is based.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This information is not provided in the summary. The "clinically apparent diagnosis of onychomychosis" implies a medical assessment, but the number or qualifications of the diagnosing experts are not detailed.

3. Adjudication method for the test set:

   • This information is not provided. The assessment of "significant apparent clearing" and "average clearance" would typically involve some form of independent assessment, but the method (e.g., 2+1, 3+1, none) is not specified.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No MRMC or AI-assisted study was mentioned. This device is a laser system, not an AI diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • This is not applicable as the device is a laser for treatment, not an algorithm for diagnosis or image analysis. The clinical study evaluated the device's therapeutic effect.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • The ground truth for the diagnosis of onychomycosis was "clinically apparent diagnosis." For the effectiveness of the treatment, the ground truth was "apparent clearing" of "dystrophic toenails," which is an outcomes-based assessment presumably made by clinicians, though specific methodology for this assessment is not detailed. The text also mentions "e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc." which implies a microbiological confirmation (pathology/laboratory testing) would be part of the diagnostic process for onychomycosis, but it's not explicitly stated as the ground truth standard for the trial's enrollment or outcome measurement.

7. The sample size for the training set:

   • This is not applicable as the document describes a physical laser device and its clinical evaluation, not a machine learning algorithm that requires a training set.

8. How the ground truth for the training set was established:

   • This is not applicable as there is no training set mentioned for this type of device submission.

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The Light Age, Inc. EpiCare-DUO™ Laser System is intended for use in general and plastic surgery, dermatology, and podiatry for the treatment of vascular lesions, benign pigmented lesions, for removal of dark tattoo inks and reduction of hypertrophic and keloid scars and for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hair regrowth after a treatment regime on all skin types (Fitzpatrick I-VI including tanned skin.) No new indications were sought in this 510(K) and no clinical data is presented.

Light Age, Inc. is providing more specialized indications which are a subset of the previously cleared indications. From both a design and clinical perspective, the predicate and candidate laser devices, are of the same technology and have the same intended use. Based upon an analysis of the overall performance characteristics for the devices, Light Age, Inc. believes that no significant differences exist.

755nm - Specifically the 755 nm mode is indicated

• Hair removal, and stable long-term or permanent hair reduction through selective targeting of melanin in hair follicles on all skin types (Fitzpatrick I-VI) including tanned skin. Permanent hair reduction is defined as long-term stable reduction in the number of hair regrowth after a treatment regime. The number of hairs re-growing must be stable over a time greater than the duration of the complete growth cycle of hair follicies, which varies from 4-12 months according to body location. Permanent hair reduction does not necessarily imply the elimination of all hairs in the treated area.
• Treatment of vascular lesions
• Treatment of benign pigmented lesions.
• Treatment of wrinkles.

1064nm -

• Removal of unwanted hair, for stable long term or permanent hair reduction on all skin types Fitzpatrick I-VI including tanned skin.
• Photocoagulation and hemostasis of pigmented and vascular lesions, such as but not limited to port wine stains, hemoangioma, warts, telangiectasia, rosacea, venus lake, leg veins, and spider veins and poikiloderma of civatte. Coagulation and hemostasis of soft tissue.
• Benign cutaneous lesions such as warts, scars striac and psoriasis.
• Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheio keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plagues.
• Pigmented lesion size reduction in patients with lesions who would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
• Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
• Treatment of pseudofolliculitis barbae (PFB).
• Treatment of wrinkles including but not limited periocular wrinkles and perioral wrinkles,

No new indications were sought in this premarket notification and no clinical data is presented.

Light Age, Inc. is providing more specialized indications which are a subset of the previously cleared indications. From both a design and clinical perspective the predicate and candidate laser devices, are of the same technology and have the same intended use. Based upon an analysis of the overall performance characteristics for the devices, Light Age, Inc. believes that no significant differences exist.

The Light Age EpiCare-DUO™ Laser is a Class IV Laser Surgical Instrument for use in General medical/cosmetic procedures, General and Plastic surgery, Podiatry, and Dermatology. Using alexandrite and neodymium (Nd) YAG crystal rods, pused energy is emitted at 755 and 1064 nanometers in the near infrared portion of the spectrum under the guidance of a visible aiming beam. The device consists of the fploving components and accessories:

1. Laser Source and Onboard Microprocessor Based Control unit
2. Laptop User Interface
3. Flexible Optical Fiber and handpiece delivers energy from the laser to the target area via optical fiber with handpiece, which produces a circular bearn on the skin.
4. Foot Pedal Switch activates delivery when lasers are enabled.

The provided text is a 510(k) summary for the Light Age EpiCare-DUO™ Laser System. A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (predicate device) that is not subject to PMA.

This document explicitly states: "No new indications were sought in this 510(K) and no clinical data is presented."

Therefore, the submission relies on demonstrating substantial equivalence to predicate devices rather than presenting new clinical study data to prove that the device meets specific performance acceptance criteria for its intended uses.

Given this, I cannot extract the following information as it is not present in the provided document:

1. A table of acceptance criteria and the reported device performance.
2. Sample sizes used for the test set.
3. Data provenance (country of origin, retrospective/prospective).
4. Number of experts used to establish ground truth.
5. Qualifications of those experts.
6. Adjudication method.
7. Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers with/without AI assistance.
8. Whether a standalone (algorithm only) performance study was done.
9. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
10. The sample size for the training set.
11. How the ground truth for the training set was established.

Summary of Device Acceptance and Compliance Information from the Provided Text:

The Light Age EpiCare-DUO™ Laser System received 510(k) clearance (K091625) based on demonstrating substantial equivalence to existing predicate devices:

• Light Age, Inc. EpiCare™ Alexandrite Laser System [K032991]
• Cynosure Apogee Elite [K034030]
• Candela Corp GentleLase Family of Lasers [K063074]

The reason for the 510(k) submission was a design change: adding a Neodymium (Nd) YAG capability to the existing EpiCare™ alexandrite laser system.

Stated Basis for Substantial Equivalence (in lieu of clinical studies for new indications):

• When operated in the 755 nm wavelength mode, the candidate device is identical in design and operation to the previously cleared EpiCare™ laser system.
• In the 1064 nm mode, the candidate device is substantially equivalent in operation and efficacy to the other predicate devices.
• The manufacturer states, "No new indications were sought in this 510(K) and no clinical data is presented."
• The manufacturer relies on the clinical safety record of the EpiCare™ product family, stating almost a decade of use with over 1 million treatments performed and no reports of significant patient or operator injury.
• The device is designed in accordance with both mandatory and voluntary standards, ensuring safety and effectiveness.

Relevant Performance Standards (not specific clinical acceptance criteria data):

• 21 CFR1040.10 and 21 CFR1040.11: Applicable performance standards for light-emitting products.
• Voluntary Electrical Equipment Standards: IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, and IEC 60601-1-22.

In conclusion, this 510(k) submission for the EpiCare-DUO™ Laser System did not involve clinical studies with specific acceptance criteria as it was based on substantial equivalence for existing indications, not new ones. Therefore, the requested details regarding clinical study methodology, sample sizes, expert involvement, and ground truth establishment are not available in this document.

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The Light Age EpiCare™ Alexandrite Laser is indicated for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs re-growing after 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.

The Light Age EpiCare™ Alexandrite Laser has an Alexandrite crystal rod as a lasing medium. Pulsed energy is emitted at 755 nanometers in the near infrared portion of the spectrum. Energy from the laser is delivered to the target area via optical fiber with handpiece, which produces a circular beam on the skin. The EpiCare™ Alexandrite Laser is equipped with safety interlocks to protect patients and operators.

This 510(k) summary does not contain the detailed study results that would allow for a complete description of acceptance criteria and device performance in the format requested. The document primarily focuses on establishing substantial equivalence to predicate devices rather than providing a standalone clinical study report with specific acceptance criteria and detailed performance metrics.

However, based on the provided text, I can infer some information relevant to the request.

Here's an attempt to answer your questions based only on the provided text, with significant limitations due to the nature of the document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria or detailed performance results in the form of percentages, p-values, or confidence intervals. The basis for safety and effectiveness is stated as "essentially the same wavelength, the same operation principle, essentially the same fluence levels, and the same spot size" as predicate devices. The indication for "permanent hair reduction" typically implies a specific percentage of hair reduction over a defined period, but this is not quantified in the provided text.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not mention any specific sample size for a test set or provide details on data provenance (e.g., country of origin, retrospective/prospective study design). This 510(k) summary relies on demonstrating substantial equivalence to pre-existing predicate devices, not on a new clinical trial with a defined test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The document does not describe a study involving human experts establishing ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. The document does not describe a study involving adjudication of a test set.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a laser for medical treatments, not an AI diagnostic or assistance system.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is a medical device (laser), not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Given the nature of a 510(k) for a laser device, the "ground truth" for its effectiveness would generally be based on clinical outcomes (e.g., observed hair reduction, visual improvement of lesions/wrinkles) from studies (either specifically for this device or, more likely in a 510(k), for the predicate devices) and expert clinical judgment. However, the document does not detail how "ground truth" was established for any specific study for this device. It primarily relies on the established safety and effectiveness of its predicate devices.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is not a machine learning or AI device that requires a training set.

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The Light Age Q-Clear™ Laser is indicated for the following uses:

1. For incision, excision, ablation, and vaporization of soft tissue for General Dermatology
2. The 1064nm wavelength is indicated for:

• Dark ink tattoo removal
• Removal of pigmented lesions (particularly Nevus of Ota)
• Removal or lightening of hair
• Skin resurfacing with or without adjuvant preparation
• Treatment of common nevi

3. The 532nm wavelength is indicated for:

• Removal of light ink (red, tan, purple and orange) tattoos
• Treatment of common nevi
• Treatment of café-au-lait spots
• Treatment of seborrheic keratoses
• Treatment of vascular lesions, including facial and leg veins, telangiectasias, angiomas, hemangiomas, port wine stains, and most pigmented lesions (e.g. lentigines, and ephelides)

The Light Age Q-Clear™ Laser has a Nd: Y AG crystal rod as a lasing medium. Pulsed energy is emitted at 1064 nanometers in the near-infrared portion of the spectrum. With the optional frequency doubler installed, a 532nm beam is emitted. The laser is delivered directly to the target area via the handpiece, which produces a circular beam on the skin. A red aiming beam is provided to allow the operator to precisely target the treatment area. The Q-Clear™ Laser is equipped with safety features in conformance with 21CFR Part 1040.

The provided text is a 510(k) summary for the Light Age Q-Clear™ Laser. It details the device's description, intended use, and claims of substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

The document is a regulatory submission for premarket notification, asserting that the device is "substantially equivalent" to previously cleared devices. This type of submission often relies on demonstrating that the new device has the same technological characteristics and intended use as predicate devices, and does not raise new questions of safety or efficacy. It generally does not include detailed performance studies with acceptance criteria in the way a clinical trial or a specific analytical performance study for a diagnostic device would.

Therefore, I cannot provide the requested information from the provided text.

Specifically, the following information is not available in the provided document:

1. A table of acceptance criteria and the reported device performance: This document asserts substantial equivalence, not specific performance metrics against defined acceptance criteria.
2. Sample size used for the test set and the data provenance: No performance study is described that would have a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no ground truth for a test set is described.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is a laser device, not an algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document's statement regarding safety and effectiveness is: "The Light Age Q-Clear™ Laser has the same wavelengths, the same spot size, the same Frie Light of operation, essentially the same fluence levels, and the same intended use as the predicate devices. The Light Age Q-Clear™ Laser does not raise new questions of safety or efficacy, and is substantially equivalent to the predicate devices." This is the core argument for its approval, not a report of meeting specific performance criteria from a new study.

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The Light Age EpiCare™ Alexandrite Laser is intended for use in dermatology for the removal of dark, unwanted body hair.

The Light Age EpiCare™ Alexandrite Laser is a medical device capable of emitting an invisible pulsed treatment laser beam with a wavelength of 755 mm under the guidance of a visible aiming beam. This laser can be utilized in either a continuous or timed-exposure mode of operation.

The provided text describes a 510(k) summary for the Light Age EpiCare™ Alexandrite Laser, claiming substantial equivalence to a predicate device, the Sharplan Model 5000 Alexandrite Laser System.

Based on the provided text, the following information regarding acceptance criteria and studies is available:

1. A table of acceptance criteria and the reported device performance:

   Acceptance Criteria	Reported Device Performance
   Substantial equivalence to predicate device (Sharplan Model 5000 Alexandrite Laser System) in design and clinical perspective.	The Light Age EpiCare™ Alexandrite Laser is stated to be of "identical design" and have the "same intended use" as the predicate device. Light Age, Inc. previously supplied internal components for the Sharplan Model 5000 and is now taking over final assembly, sales, and distribution without product changes or new indications.
   Intended use: removal of dark, unwanted body hair.	The device is intended "for use in dermatology for the removal of dark, unwanted body hair."
   Safety and effectiveness.	"The safety and effectiveness of the Light Age EpiCare™ Alexandrite Laser is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate device..." The document asserts that "As the predicate and candidate devices are identical in design and overall performance characteristics, the Light Age EpiCare™ Alexandrite Laser should not raise any concerns regarding its overall safety or effectiveness."
   Wavelength: 755 mm.	The device emits an "invisible pulsed treatment laser beam with a wavelength of 755 mm."
   Operation mode: continuous or timed-exposure.	The device "can be utilized in either a continuous or timed-exposure mode of operation."

2. Sample size used for the test set and the data provenance:

   The document does not describe a specific test set or clinical study conducted for the Light Age EpiCare™ Alexandrite Laser itself. Instead, it relies on the safety and effectiveness data of the predicate device, the Sharplan Model 5000 Alexandrite Laser System, which FDA reviewed under K973354 and K971874. A letter of authorization from ESC Medical Systems was provided to allow FDA access to this predicate data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   Not applicable, as no new clinical study data for the Light Age EpiCare™ Alexandrite Laser is presented or described in this 510(k) summary. The determination is based on the previously established ground truth for the predicate device, which is not detailed here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   Not applicable, as no new clinical study data for the Light Age EpiCare™ Alexandrite Laser is presented or described in this 510(k) summary.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   Not applicable. The device is a medical laser for hair removal, not an AI-assisted diagnostic or imaging tool involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   Not applicable. The device is a medical laser, not an algorithm. Performance is assessed based on its physical characteristics and equivalence to the predicate.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   For the Light Age EpiCare™ Alexandrite Laser, the "ground truth" for its safety and effectiveness is established by its substantial equivalence to the predicate device, the Sharplan Model 5000 Alexandrite Laser System, along with the safety and effectiveness data previously submitted for that predicate device (K973354, K971874). The specific types of ground truth (e.g., patient outcomes, clinical measurements) used in the predicate device's evaluation are not detailed in this summary.

8. The sample size for the training set:

   Not applicable. The device is a physical medical laser, not a machine learning model requiring a training set.

9. How the ground truth for the training set was established:

   Not applicable, for the same reason as point 8.

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Light and dark ink tattoo removal and pigmented lesions removal

The Alex Ta2 Eraser is a flashlamp Q-switched solid state laser producing a broadband wavelength of 755 ±25nm.

The provided text is a 510(k) summary for the Alex Ta2 Eraser, a medical laser system. Upon review, it explicitly states "Nonclinical Performance Data: None provided at this time" and "Clinical Performance Data: None provided at this time."

Therefore, based on the provided document:

1. A table of acceptance criteria and the reported device performance: No acceptance criteria or reported device performance are provided as no clinical or nonclinical performance data was submitted. The device was deemed substantially equivalent to a predicate device without this data.
2. Sample sized used for the test set and the data provenance: Not applicable, no test set was used as no performance data was provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, no test set was used.
4. Adjudication method for the test set: Not applicable, no test set was used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, no studies were done. The device is a laser system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, no performance studies were done. The device is a laser system, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable, no performance studies were done.
8. The sample size for the training set: Not applicable, no performance studies were done. The device is a laser system, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable, no performance studies were done and no training set for an algorithm was needed.

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