Long pulse Nd:YAG Laser System is intended for use for :
• Benign pigmented lesions such as but not limited to , lemtigos( age spots), solar lentigos( sun spots), café au lait macules, sebortheic karatoses, nevi, chloasma, verucae, skin tags, karatoses, tattoss( significant reduction in the intensity of black and/or blue black tattoos) and plaques.
• Pigmented lesions to reduce lesion size, for patients with lesions that would potiently 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.

Device Description

The Long Pulse Nd:YAG Laser System is a flashlamp-excited, Nd:YAG (Neodymium-doped Yttrium Aluminum Garnet) laser system. Pulsed laser energy at a nominal wavelength of 10641m. This wavelength causes maximum energy absorption by targeting the treatment area and minimum absorption by surrounding skin structures. In addition, the laser pulse duration is controlled to be equal to or shorter than the thermal relaxation time of the target, to minimize heat transfer to surrounding tissues.
Deeper penetration and a more moderate hemoglobin absorption makes 1064 nm wavelength more useful for the deeper hair follicles and vessels. Further, with the right combination of parameters, the 1064 nm wavelength is also suitable for more superficial hair, telangiectasia and spider veins.
Base on this, Long Pulse Nd: Y AG Laser System is intended for 1) Benign pigmented lesions such as ,but not limited to , lemtigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic karatoses, nevi, chloasma, verrucae, skin tags, karatoses, tattoss (significant reduction in the intensity of black and/or blue black tattoos) and plaques. 2) Pigmented lesion size, for patients with lesions that would potiently benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. 3) Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
The Nd: Y AG Laser System consists of control system, user interface, power source , laser emission and delivery system, cooling system and safety features

AI/ML Overview

The provided document is a 510(k) summary for a medical device called "Long Pulse Nd:YAG Laser System." It's a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. This type of document focuses on comparing the new device to existing ones rather than detailing a clinical study with acceptance criteria and device performance in the way a clinical trial report would.

Therefore, much of the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not present in this 510(k) summary.

Here's what can be extracted and inferred from the document:

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

Acceptance Criteria: Not explicitly stated as pass/fail thresholds for clinical performance metrics. The document focuses on showing substantial equivalence in intended use, technological characteristics, and principles of operation to a predicate device.
Reported Device Performance: No clinical performance metrics (e.g., success rates, lesion reduction percentages, complication rates) are reported. The document states that "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device." This implies performance was deemed acceptable if it matched the predicate's capabilities or standards, but specific numbers are absent.

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

Sample Size for Test Set: Not applicable. This document refers to non-clinical tests (electrical safety, EMC, laser safety standards) and a comparison to a predicate device, not a human clinical test set.
Data Provenance: Not applicable for a clinical test set. The non-clinical tests were presumably conducted by the manufacturer, Advanced Technology Laser Company, Ltd., based in Shanghai, China.

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)

Number and Qualifications of Experts: Not applicable. No human expert-adjudicated ground truth data is presented.

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

Adjudication Method: Not applicable. No human test set requiring adjudication is described.

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

MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a laser system, not an AI or diagnostic imaging device that would typically involve human readers interpreting results.

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

Standalone Performance: Not applicable. This is a physical laser device, not a software algorithm.

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

Type of Ground Truth: Not applicable for clinical performance. The "ground truth" for the non-clinical tests refers to compliance with established international standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1).

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This a physical laser system, not an AI/machine learning device that would require or report a training set.

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

Ground Truth for Training Set: Not applicable.

Summary of Information from the Document:

While the document does not contain the specific information requested, it does provide key details about the device and its regulatory submission:

Device Name: Long Pulse Nd:YAG Laser System (Trade Name: SmoothTouch)
Manufacturer: Advanced Technology Laser Company, Ltd. (Shanghai, China)
Regulatory Number: K140249
Intended Use:
- Treatment of benign pigmented lesions (lentigos, solar lentigos, café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos - significant reduction in black/blue-black intensity, and plaques).
- Reduction of pigmented lesion size for aggressive treatment or non-responsive lesions.
- Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is integral.
Predicate Device: Gentle YAG Laser System (Candela Corporation), K022923
Technological Characteristics Comparison (Proposed vs. Predicate):
- Product Code: GEX (SAME)
- Regulation Number: 21CFR 878.4810 (SAME)
- Intended Use: SAME
- Energy Source: ND:YAG Laser (SAME)
- Waveform: 1064 nm (SAME)
- Fluence energy range: up to 600J/cm2 (SAME)
- Spot size: 1.5mm, 3mm, 8mm, 10mm, 12mm and 3mm*8mm (SIMILAR)
- Aiming laser: 510nm diode laser (<5mW), Class III (SIMILAR)
- Beam Delivery: Permanently attached umbilical cable and handpieces (SAME)
Non-Clinical Test Conclusions: Device met all design specifications and was substantially equivalent to the predicate device in non-clinical tests. It complies with IEC 60601-1, IEC60601-1-2, IEC 60601-2-22, and IEC 60825-1 standards. These standards encompass general requirements for safety, electromagnetic compatibility, particular requirements for laser equipment safety, and safety of laser products related to classification and requirements.
Regulatory Class: Class II
Product Code: GEX

This 510(k) submission demonstrates substantial equivalence primarily through technical comparison and compliance with relevant safety standards, rather than direct clinical performance data from a specific study against predefined acceptance criteria.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

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

October 8, 2014

Advanced Technology Laser Company, Ltd % Ms. Diana Hong Mid-Link Consulting Company, Ltd P.O. Box 120-119 Shanghai, 200120 CHINA

Re: K140249

Trade/Device Name: Long Pulse Nd:YAG Laser System 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: GEX Dated: September 5, 2014 Received: September 8, 2014

Dear Ms. Hong:

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 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

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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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours, Binita S. Ashar -S 2014.10.08 12:44:48 -04'00' Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K140249

Device Name

Long Pulse Nd: Y AG Laser System

Indications for Use (Describe)

Long pulse Nd: Y AG Laser System is intended for use for :

· Benign pigmented lesions such as but not limited to , lemtigos( age spots), solar lentigos( sun spots), café au lait macules, sebortheic karatoses, nevi, chloasma, verucae, skin tags, karatoses, tattoss( significant reduction in the intensity of black and/or blue black tattoos) and plaques.

• Pigmented lesions to reduce lesion size, for patients with lesions that would potiently 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.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Section 3 510(k) Summary

This 510(k) Summary of 510(k) information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: K140249

1. Date of Submission: 09/10/2014
Sponsor Identification 2.

Advanced Technology Laser Co., Ltd. 920 Jian-chuan Road, Bldg. A2, Level 5,Shanghai, 200240, China

Establishment Registration Number: 3007604279;

Contact Person: Mingxia Xi Position: Regulator Affair Director Tel: +86-21-5471 2151 Fax: +86-21-5471 2152 Email: xmx@at-laser.com

1. Submission Correspondent
  Ms. Diana Hong& Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net

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Proposed Device Identification 4.
Trade Name: Long Pulse Nd: YAG Laser System; Common Name: Nd:YAG Dermatology Laser System; Model: SmoothTouch;

Regulatory Information: Classification Name: Powered Laser Surgical Instrument; Classification: II; Product Code: GEX; Regulation Number: 21CFR 878.4810; Review Panel: Laser Instrument, Surgical, Powered;

Intended Use Statement:

Long pulse Nd:YAG Laser System is intended for use for :

Benign pigmented lesions such as ,but not limited to , lemtigos( age spots), solar lentigos( sun spots), café au lait macules, seborrheic karatoses, nevi, chloasma, verrucae, skin tags, karatoses, tattoss( significant reduction in the intensity of black and/or blue black tattoos) and plaques.
. Pigmented lesions to reduce lesion size, for patients with lesions that would potientlly 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.
Predicate Device Identification ર.

510(k) Number: K022923 Product Name: Gentle YAG Laser System Manufacturer: Candela Corporation

1. Device Description
  The Long Pulse Nd:YAG Laser System is a flashlamp-excited, Nd:YAG (Neodymium-doped Yttrium Aluminum Garnet) laser system. Pulsed laser energy at a nominal wavelength of 10641m. This wavelength causes maximum energy absorption by targeting the treatment area and minimum absorption by surrounding skin structures. In addition, the laser pulse duration is controlled to be equal to or shorter than the thermal relaxation time of the target, to minimize heat transfer to surrounding tissues.

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Deeper penetration and a more moderate hemoglobin absorption makes 1064 nm wavelength more useful for the deeper hair follicles and vessels. Further, with the right combination of parameters, the 1064 nm wavelength is also suitable for more superficial hair, telangiectasia and spider veins.

Base on this, Long Pulse Nd: Y AG Laser System is intended for 1) Benign pigmented lesions such as ,but not limited to , lemtigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic karatoses, nevi, chloasma, verrucae, skin tags, karatoses, tattoss (significant reduction in the intensity of black and/or blue black tattoos) and plaques. 2) Pigmented lesion size, for patients with lesions that would potiently benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. 3) Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.

The Nd: Y AG Laser System consists of control system, user interface, power source , laser emission and delivery system, cooling system and safety features

1. Non-Clinical Test Conclusion
  Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

IEC 60601-1:2005, Medical Electrical Equipment - Part 1: General requirements for safety.

IEC60601-1-2:2007, Medical Electrical Equipment - Part 1: General requirements for safety - 2, Collateral Standard: Electromagnetic compatibility - Requirements and tests.

IEC 60601-2-22:2007, Medical Electrical Equipment - Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment.

IEC 60825-1: 2007, Safety of laser products - Part 1: Equipment classification, requirements

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Section 3 510 Summary

8. Substantially Equivalent (SE) Conclusion

The following table compares the DEVICE to the predicate device with respect to intended use, technological characteristics and principles of operation, etc.

Item	Proposed Device(s)	Predicate Device
Product Code	GEX	GEX
Regulation Number	21CFR 878.4810	21CFR 878.4810
Intended Use	Long pulse Nd:YAG Laser System is intended for use for :Benign pigmented lesions such as ,but not limited to , lemtigos( age spots), solar lentigos( sun spots), café au lait macules, seborrheic karatoses, nevi, chloasma, verrucae, skin tags, karatoses, tattoss( significant reduction in the intensity of black and/or blue black tattoos) and plaques.Pigmented lesions to reduce lesion size, for patients with lesions that would potientlly 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.	SAME
Energy Source	ND:YAG Laser	SAME
Waveform	1064 nm	SAME
Fluence energy range	up to 600J/cm2	SAME
Spot size	1.5mm, 3mm, 8mm, 10mm, 12mm and 3mm*8mm	SIMILAR
Aiming laser	510nm diode laser (<5mW), Class III	SIMILAR
Beam Delivery	Permanently attached umbilical cable and handpieces	SAME

Table 3-1 Comparison of Technology Characteristics

The proposed device, Long Pulse Nd:YAG Laser System, is determined to be Substantially Equivalent (SE) to the predicate device, Gentle YAG Laser System, in respect of safety and effectiveness.

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.