(219 days)
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 :
- 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.)
- 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
- 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:
- Dermatology and Plastic Surgery for incision, excision, vaporization, coagulation of soft tissues including spider veins:
- 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)
| Characteristic | Acceptance Criteria (Predicate Range/Standard) | Reported Device Performance (Light Age Q-Clear™ Nd:YAG) |
|---|---|---|
| Lasing Medium | Nd:YAG rod | Nd:YAG rod |
| Aiming Beam | 630-680 nm (≤ 2.5mW) / Yes | 630-680 nm (≤ 2.5mW) |
| Wavelength | 1064 nm or 1064 / 532nm | 1064nm (LP Model), 1064 / 532nm (Q-Switched Model) |
| Maximum Power (Watts) | 4W - 14W | 6W |
| Maximum Energy Per Pulse | 200mJ - 7J (predicates) | LP: 200mJ; Q-Switched: *400mJ (up to 725 mJ/Pulse across 4 levels) |
| Maximum Pulse Duration | nsec to msec ranges across predicates | LP: 100-200, 100-3000 msec; Q-Switched: 3 - 10 nsec |
| Output mode | Pulsed, multi-mode | Pulsed, multi-mode |
| Repetition Rate | 1-100 Hz | 1 - 5 Hz (LP Model), 1 – 5 Hz, Variable (Q-Switched Model) |
| Laser Media (Pumped type) | Flashlamp-Pumped solid-state laser rod | Flashlamp - Pumped solid-state laser rod |
| User interface | Push button control panel | Push button control panel |
| User Activation | Footswitch / Finger or Footswitch | Footswitch |
| Delivery Devices (Supply) | Non-sterile, reusable, cleanable, sterilizable | Non-sterile, reusable, cleanable, sterilizable |
| System Dimensions (H x W x D) | Varies significantly across predicates | 10" x 14" x 16" |
| System Weight | 17.2 kg - 61 kg | 16 Kg (35 lbs) |
| Electrical Requirements | 90-240VAC, 50/60Hz | 120/220-240VAC 50/60Hz; 10/5A; Single Phase |
Table 2: Acceptance Criteria (Clinical) and Reported Device Performance
| Indication | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Temporary increase of clear nail in onychomycosis | Implied: Demonstrated substantial effective clearance, with statistical significance and acceptable patient toleration/safety, comparable to established treatments. | Significant apparent clearing in 95% of subjects, with an average clearance of affected areas of 56±7% at 98% level of confidence. Well-tolerated with no pain reported; 100% patient satisfaction. No significant adverse reactions. |
Study Details
The provided text details one specific clinical study related to the onychomycosis indication.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.