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)

Device Description

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

AI/ML Overview

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.

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.
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.
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.
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.
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.
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.
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.
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.

Summary

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Light Age, Inc.

SEP 1 5 2011

510(k) Summary

Light Age, Inc. Q-Clear™ Nd:YAG Laser

Submittal Information:

Post Approval Contact: Dr. Donald F. Heller, Chief Executive Officer Elizabeth Reddington, Director of Regulatory Affairs Light Age, Inc. 500 Apgar Drive Somerset, NJ 08873 Tel: 732-563-0600 Fax: 732-563-1571

Device Name and Classification:

510(k) Number:	K110370
Proprietary Name:	Light Age Q-Clear™ Laser System
Common Name:	Nd:YAG Laser System
Classification Name:	Class IV Laser Surgical Instrument
Classification Panel :	General & Plastic Surgery Devices
C.F.R. Section	878.4810
Device Class:	II
Product Code:	GEX

Predicate Devices:

♥ Light Age Q-Clear™ Laser [K033259], manufactured by Light Age, Inc., 500 Apgar Drive, Somerset, NJ 08873
Pinpointe FootLaser™ [K093545 and K093547], manufactured by Pinpointe USA, Inc, 275 . Airpark Boulevard, Suite 100, Chico, CA 95973
. Cutera GenesisPlus Laser System [K103626], manufactured by Cutera, Inc., 3240 Bayshore Blvd., Brisbane, CA 94005
Palomar Q-YAG 5™ Nd:YAG Laser System [K061436], manufactured by Palomar Medical . Technologies, Inc. 82 Cambridge Street, Burlington, MA 01803
. Family of Altus Medical CoolGlide Aesthetic Lasers (K022226), manufactured by Altus Medical, Inc. 821 Cowan Road, Burlingame, CA 94010

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Description:

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 ﻗ
- Footswitch connector ﻥ
- Power Cord connector ರ.
(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

Indications For Use:

The 1064nm wavelength is indicated for :

1. Podiatry for incision, excision, vaporization, coagulation of soft tissues including:
- Matrixectomy ー
- Warts including periungual, subungual, and plantar warts l
- Radical nail excision -
- Neuromas -
- The Q-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.)
1. Dermatology and Plastic Surgery for incision, excision, vaporization, vaporization of soft tissues including:
- -Lesions of the skin and subcutaneous tissue
- Spider veins 一
- Plantar Warts ー
- Periungual and subunqual warts l
- Debridement of decubitus ulcer l
- -Treatment of keloids

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General Dermatology

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

The 532 nm wavelength is indicated for:

1. Dermatology and Plastic Surgery for incision, excision, vaporization, coagulation of soft tissues including:
- । Spider veins
1. General Dermatology
- Removal of light ink (red, tan, purple, and orange) tattoos l
- Treatment of common nevi l
- Treatment of café-au-lait spots -
- Treatment of seborrheic keratoses -
- Treatment of vascular lesions, including facial and leg veins, telangiectasias, ー
- angiomas, hemangiomas, port wine stains, and most pigmented lesions (e.g. lentigines, and ephelides)

Summary of Clinical Tests:

Light Age, Inc.'s study of 100 randomized subjects of both genders, including Caucasian, Asian, African American, and Latino, has demonstrated substantially effective clearance of dystrophic toenails having a clinically apparent diagnosis of onychomychosis. Statistical analysis of results indicates significant apparent clearing in 95% of the subjects with an average clearance of affected areas of 56±7% at 98% level of confidence. The protocol employed was extremely well tolerated by patients, no pain was reported, although some patients reported feeling a low-level sensation on some involved toenails. Reported patient satisfaction was 100%. No significant adverse reactions or responses were observed or reported.

The Q-Clear™ Laser System is indicated for use for the temporary increase of clear nail in patients with onychornycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.)

Performance Standards:

The Q-Clear™ Nd:YAG Laser System complies with applicable performance standards for light . emitting products as outlined in 21 CFR1040.10 and 21 CFR1040.11.
The device also conforms to the voluntary electrical equipment standards: IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, and IEC 60601-1-22.

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Summary of Technological Characteristics:

The technological characteristics of the Q-Clear™ Nith the Long Pulse (LP) Head is substantially equivalent to the predicate device, having performance parameters within the latter's characteristic envelope – see table below:

	Current Submission		Predicate Device A	Predicate Device B	Predicate Device C
Characteristic	Q-Clear™ Nd:YAG		Pinpointe FootLaser™(K093547)	Family of AltusCoolGlide™ AestheticLasers (K022226)	Palomar Q-YAG 5™Nd:YAG Laser System(K061436)
Lasing Medium	Nd:YAG rod		Nd:YAG rod	Nd:YAG rod	Nd:YAG rod
Aiming Beam	630-680 nm (≤ 2.5mW)		630-680 nm (≤ 2.5mW)	Yes	Yes
Wavelength	1064nm	1064 / 532nm	1064 nm	1064 / 532nm	1064 / 532nm
Model	LP	Q-Switched	"6W" Pinpoint Foot Laser	CoolGlide™	Q-YAG 5™
Maximum Power(Watts)	6W	6W	6W	14W	4W
Maximum EnergyPer Pulse	200mJ	*400mJ	200mJ	7J	400mJ
Maximum PulseDuration	100-200 3 - 10 nsec 100-3000 0.1-300msec 3 nsec
Output mode	Pulsed,multi-mode	Pulsed,multi-mode	Pulsed,multi-mode	Pulsed,multi-mode	Pulsed,multi-mode
Repetition Rate	1 - 5 Hz	1 – 5 Hz,Variable	5-100 Hz	Single shot, up to 2 Hz	1-10 Hz
Laser Media	Flashlamp -Pumped solid state laser rod		Flashlamp -Pumped solid state laserrod	Flashlamp -Pumped solid statelaser rod	Flashlamp -Pumped solid state laserrod
User interface	Push button control panel		Push button control panel	Push button controlpanel	Push button control panel
User Activation	Footswitch		Footswitch	Footswitch	Finger or Footswitch
Delivery Devices(How supplied)	Non-sterile, reusable, cleanable,sterilizable		Non-sterile, reusable,cleanable sterilizable	Non-sterile, reusable,cleanable, sterilizable	Non-sterile, reusable,cleanable sterilizable

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Light Age, Inc.

Q-Clear™ Nd:YAG Laser

Characteristic	Current Submission	Predicate Device APinpointe FootLaser™(K093547)	Predicate Device BFamily of AltusCoolGlide™ AestheticLasers (K022226)	Predicate Device CPalomar Q-YAG 5™Nd:YAG Laser System(K061436)
	Q-Clear™ Nd:YAG
SystemDimensions	10" x 14" x 16" ( H x W x D)	32" x 13"x 14"(H x W x D)	12" x 19" x 35"(W x D x H)	18" (45.7 cm) L x 19"(48.3 cm) H x 17" (43.2cm) D
System Weight	16 Kg (35 lbs)	17.2 kg (38 lbs)	61 kg (135 lbs)	Upper Module, 35 lbs.(15.8 kg); Lower Module,35 lbs. (15.8 kg); Arm, <15lbs. (6.8 kg); Handpiece,<3 lbs. (1.4 kg)
ElectricalRequirements	120/220-240VAC 50/60Hz;10/5A; Single Phase	90-130 VAC 50/60 Hz200-240 VAC, 50/60 Hz	110-230V 50/60 Hz	100 – 240V, 50/60Hz

Maximum Energy Per Pulse is set by the levels below:

Level 1 is equivalent to 350 mJ/Pulse. Level 2 is equivalent to 500 mJ/Pulse. Level 3 is equivalent to 600 mJ/Pulse. Level 4 is equivalent to 725 mJ/Pulse.

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Substantial Equivalence

The reason for this 510(k) is based on new indications for use. Light Age, Inc. is adding new indications for use to our existing Q-Clear™ Nd:YAG laser system that has been cleared and in use since 2003 with no FDA reportable events.

The Light Age Q-Clear™ Nd:YAG Laser is substantially equivalent to the predicate devices listed above (Light Age Q-Clear™ Laser (K033259), Pinpointe FootLaser™ (K093547), Family of Altus CoolGlide™ Aesthetic Lasers (K022226), and the Palomar Q-YAG 5™ Nd:YAG Laser System (K061436)), with the same wavelengths, the same principles of operation, and essentially the same fluence levels. The differences in the specifications between the Q-Clear™ and the predicate device does not raise new questions of safety or efficacy.

Safety and Effectiveness:

The Light Age, Inc. Q-Clear™ Nd:YAG Laser System should not raise any concerns regarding its overall safety and effectiveness. In the nearly seven (7) years of use with over 500,000 treatments performed the Q-Clear™ Nd:YAG Laser has been proven to be clinically safe with no reports of significant patient or operator Injury.

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 13, 2013

Light Age, Inc. % Ms. Elizabeth Reddington Director of Regulatory Affairs 500 Apgar Drive Somerset, New Jersey 08873-1150

Re: K110370

Trade/Device Name: Q-Clear™ Nd:YAG Laser Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: PDZ, GEX Dated: September 09, 2011 Received: September 12, 2011

Dear Ms. Reddington:

This letter corrects our substantially equivalent letter of September 15, 2011.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act

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Page 2 - Ms. Elizabeth Reddington

or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801; medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm.

Sincerely yours, FOR

Peter D. Rumm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT:

510(K) Number: K110370

Device Name: Q-Clear™ Nd:YAG Laser

Indications for Use:

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 ﺖ
- Radical nail excision ー
- -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.)
1. Dermatology and Plastic Surgery for incision, excision, vaporization, coagulation of soft tissues including:
- Lesions of the skin and subcutancous tissue l
- Spider veins -
- Plantar Warts -
- Periungual and subungual warts l
- Debridement of decubitus ulcer ー
- Treatment of keloids -
1. General Dermatology
- Dark ink tattoo removal ー
- Treatment of pigmented lesions (particularly Nevus of Ota) l
- -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:
1. General Dermatology
- Removal of light ink (red, tan, purple, and orange) tattoos 1
- Treatment of common nevi ಲ
- Treatment of café-au-lait spots -
- Treatment of seborrheic keratoses

Treatment of vascular lesions, including facial and leg veins, telangiectasias, angiomas, (Division Sign-Off) (Division Sign-Off) Division of Surgers and Restorative (P

(Please Do Not Write Below This Line - Continue on Another Page If Needed)

510(k) Number

X Prescription Use (Per 21 CFR 801.109)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Over the Counter Use _

Regulation Number and Section

§ 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.