The ATL Family of CO2 Medical Laser Systems (and the delivery accessories that are used to deliver laser energy) are indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.

Dermatology, Plastic Surgery and General Surgery procedures including but not limited to -

A Treatment of furrows and wrinkles
A Removal of skin tags, actinic keratosis, acne scars, keloids, tattoos, telangiectasia, squamous and basel cell carcinoma, warts and uneven pigmentation,
A Treatment of cysts, abscesses, hemorrhoids and other soft tissue applications.
A Blepharoplasty
V Site preparation for hair transplants

Dental procedure including but not limited to

ア Periodontal procedures such as - gingivectomy, removal of hyperplasias, gingivonlasty (incision and excision)
Oral Surgery procedures such as - aphous ulcer excision, frenectorny, benignimalignant lesion ablation, operculectomy and homeostasis

Podiatry procedures including but not limited to -

Ablation, vaporization and excision of soft tissue lesions such as ingrown nail, fungal nail, porokeratoma, matrixectomy and verrucae vulgares.
Otorhinolaryngology (ENT) procedures including but not limited to -
ア Treatment of leukoplakia of larynx, nasal obstruction, rhinophyma, verrucae vulgares, choanal atresia, LAUP and papillomatosis polyps.
Gynecology
V Treatment of condyloma acuminata, cervical intracpithelial neoplasia, leukoplakia and vulvar/vaginal intraepithelial neoplasia, cervical dysplasja.

Device Description

The ATL Family of CO2 Medical Laser Systems is a microprocessor-controlled CO2 laser system using a sealed laser tube providing either 15 watts maximum power (ATL-150) or 25 watts maximum power (ATL-250).

The ATL Family of CO2 Medical Laser Systems is intended to be used to deliver 10.6um CO2 light energy in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties.

The ATL Farnily of CO2 Medical Laser Systems covers control system, user interface, power supply, laser emission and delivery system, cooling system and safety features.

AI/ML Overview

This 510(k) summary (K083918) for the ATL Family of CO2 Medical Laser Systems indicates that no clinical studies were required or performed to demonstrate substantial equivalence or meet acceptance criteria. The submission relies entirely on non-clinical testing and comparison to a predicate device.

Therefore, many of the requested details cannot be provided as they pertain to clinical studies.

Here's the breakdown of what can be extracted from the provided document:

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

The document does not provide a table of specific acceptance criteria in terms of performance metrics (sensitivity, specificity, etc.) for the device. Instead, acceptance is based on adherence to recognized standards and verification through laboratory testing that the device met its design specifications and was substantially equivalent to the predicate.

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with International and US Standards (Safety, EMC, QMS)	The device "met all design specifications" and complied with:
	- IEC 60825-1: 2007
	- IEC 60601-2-22:2007
	- IEC 60601-1:1988+A1:1991+A2:1995
	- IEC60601-1-2:2001+A1:2004
	- European Medical Directive 93/42/EEC
	- US Federal Performance Standards 21 CFR 1002.10 requirements
	- Part 820 - Quality System Regulation
	- ISO9001 and ISO13485 System Certification
Substantial Equivalence to Predicate Device	"Laboratory testing was conducted to validate and verify that the proposed device... was substantially equivalent to the predicate device." The device shares "same indications for use and safety compliance, similar design features, functional features."

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

Not applicable. No clinical test set was used. "No Clinical Information is required."

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. No clinical test set or ground truth established by experts for clinical performance.

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

Not applicable. No clinical 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. No AI component. No MRMC study was done. This is a medical laser system, not an AI diagnostic device.

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

Not applicable. This is a medical laser system, not an algorithm. Performance was evaluated based on meeting design specifications and safety standards.

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

Not applicable for clinical performance. For non-clinical validation, the "ground truth" was adherence to established engineering standards and design specifications, verified through laboratory testing.

8. The sample size for the training set

Not applicable. No training set was used as this is not an AI/machine learning device.

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

Not applicable. No training set.

Summary

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K083918

Image /page/0/Picture/1 description: The image shows the logo for Advanced Technology Laser Co., LTD. The logo includes the company's initials, ATL, in a stylized font inside of a circle. Below the company name is the text "510(k) Summary".

FEB = 2 2009

I 2

Exhibit #B 510(k) Summary

ATL Family of CO2 Medical Laser Systems Advanced Technology Laser Co., Ltd

(As required by 21 CFR 807.92)

Date Prepared: November 4, 2008

2. Sponsor Information

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

Contact Person Mingxia Xi, Director for Regulatory Affairs Phone: (+86) 21 5471-2151 Fax: (+86) 21 5471-2152

3. Submission Correspondent

Ms. Diana Hong

Mr. Lee Fu

Shanghai Mid-Link Business Consulting Co., Ltd Suite 8D, No.19, Lane 999, Zhongshan No.2 Road(S) Shanghai, 200030, China Tel: +86-21-64264467 Fax: +86-21-64264467-809

Email: Diana,hong@mid-link.net

4. Proposed Device Information

Device Common or Usual Name: Carbon dioxide laser;

Device Trade or Proprietary Name: ATL Family of CO2 Medical Laser Systems; Model: ATL-150, ATL-250;

Classification Name: laser instrument, surgical, powered;

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Image /page/1/Picture/0 description: The image shows a logo with the letters "ATL" in a stylized, bold font. The letters are arranged in a slightly overlapping manner, with the "A" on the left, the "T" in the middle, and the "L" on the right. The entire logo is enclosed within a circle, with a small portion of the circle missing at the bottom. The logo appears to be a simple, yet distinctive design.

ADVANCED TECHNOLOGY LASER CO., LTD. 510(k) Summary

Regulation Number: 21 CFR 878.4810; Product Code: GEX

Panel: 878 General and Plastic Surgery

5. Predicate Device

SLIM Evolution Family of CO2 Lasers and Delivery Device Accessories (K063001)

6. Device Description

The ATL Farnily of CO2 Medical Laser Systems covers control system, user interface, power supply, laser emission and delivery system, cooling system and safety features.

7. Intended Use

The ATL Family of CO2 Medical Laser Systems (and the delivery accessories that are used to deliver laser energy) are indicated for use in surgical applications requiring the ablation, vaporization, excision, and coagulation of soft tissue in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology,

6. Substantial Equivalence

The ATL Family of CO2 Medical Laser Systems share the same indications for use and safety compliance, similar design features, functional features, and therefore are substantially equivalent to the predicate device, the SLIM Evolution Family of CO2 Lascrs and Delivery Device Accessories (K063001). In addition, a review of the predicate device demonstrate that the ATL Family of CO2 Medical Laser Systems is safe and effective as the predicate device as they share

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Image /page/2/Picture/0 description: The image shows a logo with the letters "ATL" inside of a circle. The letters are stylized and appear to be connected. The logo has a slightly distressed or textured appearance, as if it has been printed or stamped. The circle is not perfectly smooth, adding to the overall vintage or worn look of the design.

ADVANCED TECHNOLOGY LASER CO., LTD. 510(k) Summary

equivalent wavelengths, and are used to perform the same indicated surgical procedures. Therefore the proposed device is substantially equivalent (SE) to the predicate device.

7. Testing

The ATL Family of CO2 Medical Laser Systems is designed, tested and will be manufactured in accordance with both mandatory and voluntary standards, including:

IEC 60825-1: 2007, Safety of laser products - Part 1: Equipment classification, requirements and user's guide.
. IEC 60601-2-22:2007, Medical Electrical Equipment - Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment.
IEC 60601-1:1988+A1:1991+A2:1995; Medical Electrical Equipment Part 1: General requirements for safety.
. IEC60601-1-2:2001+A1:2004, Medical Electrical Equipment - Part 1: General requirements for safety-2, Collateral Standard: Electromagnetic compatibility - Requirements and tests.

The devices also comply with European Medical Directive 93/42/EEC and the US Federal Performance Standards 21 CFR 1002.10 Requirements (21CFR 1040.10 and 21CFR 1040.11 for Class IV Laser Products), Part 820 - Quality System Regulation, and have passed ISO9001 and ISO13485 System Certification.

Non-Clinical Conclusion:

Laboratory testing was conducted to validate and verify that the proposed device. ATL Family of CO2 Medical System met all design specifications and was substantially equivalent to the predicate device.

Clinical Conclusion: No Clinical Information is required.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

Public Health Service

FEB = 2 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Advanced Technology Laser Co., Ltd % Underwriters Laboratories, Inc. Mr. Morten Simon Christensen 455 E. Trimble Road San Jose, California 95131-1230

Re: K083918

Trade/Device Name: ATL Family of CO2 Medical Laser Systems Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: January 16, 2009

Received: January 23, 2009

Dear Mr. Christensen:

We have reviewed vour 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set

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Page 2 - Mr. Morten Simon Christensen

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,

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours.

Mark M. Millerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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ADVANCED TECHNOLOGY LASER CO., LTD. 510(k) Submission Report - Indications for Use Statement

Section II Indications for Use Statement

്കാം വേണ്ടിക്കുന്നത്. അവലംബം കോട്ടിക വിക്കുന്നത്. കാലക്കുന്നത് ഇവ കാലത്തിലെ സമ്മാനമായിരുന്നു. അവലംബം സമ്മാനമായ സമ

510(k) Number: Device Name:

ATL Family of CO2 Medical Laser Systems

Indications for Use:

Dermatology, Plastic Surgery and General Surgery procedures including but not limited to -

A Treatment of furrows and wrinkles
A Removal of skin tags, actinic keratosis, acne scars, keloids, tattoos, telangiectasia, squamous and basel cell carcinoma, warts and uneven pigmentation,
A Treatment of cysts, abscesses, hemorrhoids and other soft tissue applications.
A Blepharoplasty
V Site preparation for hair transplants

Dental procedure including but not limited to

ア Periodontal procedures such as - gingivectomy, removal of hyperplasias, gingivonlasty (incision and excision)
Oral Surgery procedures such as - aphous ulcer excision, frenectorny, benignimalignant lesion ablation, operculectomy and homeostasis

Podiatry procedures including but not limited to -

Ablation, vaporization and excision of soft tissue lesions such as ingrown nail, fungal nail, porokeratoma, matrixectomy and verrucae vulgares.
Otorhinolaryngology (ENT) procedures including but not limited to -
ア Treatment of leukoplakia of larynx, nasal obstruction, rhinophyma, verrucae vulgares, choanal atresia, LAUP and papillomatosis polyps.

Gynecology

V Treatment of condyloma acuminata, cervical intracpithelial neoplasia, leukoplakia and vulvar/vaginal intraepithelial neoplasia, cervical dysplasja.
1

Prescription Use	X	AND/OR	Over-The-Counter Use
(Part 21 CFR 801 Subpart D)			(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of ODRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

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Division of General, Restorative, and Neurological Devices

510(k) Number 1108351Y

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.