The equipment is used for human tissue vaporization. coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology,
The equipment is used for human tissue vaporization in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology,

Device Description

Trixel CO2 Laser is a carbon dioxide laser used in medical and aesthetic industry for treatment of such skin conditions as fine and coarse wrinkles, scars of various origin, uneven pigmentation and dilated pores. Due to the CO2 laser's high absorption of water, its high-energy beam of laser light interacts with the skin's surface causing the upper layer to peel off and use photothermolysis to stimulate deep cell regeneration and then achieve the target of skin improvement.
The equipment is mainly used for human tissue vaporization, coagulation and exposure to achieve the purpose of treatment.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is a 510(k) summary for a CO2 Laser, focusing on demonstrating substantial equivalence to a predicate device rather than providing a performance study against predefined acceptance criteria.

The summary outlines:

Device Identification and Intended Use: The proposed device (Trixel CO2 Laser/Trixel II CO2 Laser) is intended for human tissue vaporization and coagulation in various surgical specialties.
Predicate Device Identification: The predicate device is the CO2 LASER SYSTEM (K101555) from ADVANCED TECHNOLOGY LASER CO., LTD.
Device Description: Details the components of both Trixel CO2 Laser models.
Non-Clinical Test Conclusion: States that bench tests were conducted to verify the proposed device met design specifications and was substantially equivalent. It lists compliance with several IEC standards (IEC 60825-1: 2007, IEC 60601-2-22: 2007, IEC 60601-1:1988+A1:1991+A2:1995, IEC60601-1-2:2001+A1:2004). These standards relate to laser safety, medical electrical equipment safety, and electromagnetic compatibility.
Substantial Equivalence Conclusion: Compares the proposed device to the predicate device, highlighting similarities in product code, regulation number, class, maximum power, work mode, wavelength, mode structure, spot size, and pulse setting. It addresses minor differences (intended use, light arm, aiming beam, cooling system, power input) with analyses concluding they do not introduce safety or effectiveness problems.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance tables, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance studies from the provided text. The document focuses on regulatory compliance through substantial equivalence, which primarily involves comparing the new device to an existing legally marketed device based on technical specifications and safety standards, rather than conducting new clinical performance trials with specific acceptance criteria.

Summary

{0}------------------------------------------------

Page (1) of (4)

Section III 510(k) Summary

Project #: MIDI INK0382010Bd

1 9 2011

Section III 510(k) Summary

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

The assigned 510(k) Number:

Date of Submission: 2010.12.21 2. Sponsor Beijing Syntech Laser Co., Ltd. 5F, No.1 Building, No.65 Jiancaicheng West Road, Xisanqi, Haidian District, Beijing, 100096, P.R.China Contact Person: Jin Jinghua Position: Vice general manager Tel: +86-10-82939866-234 Fax: +86-10-82935528 Email: sales@syntechlaser.com
Submission Correspondent Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 237-023, Shanghai, 200237, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net
Proposed Device Identification

Proposed Device Name: Trixel CO2 Laser/ Trixel II CO2 Laser Proposed Device Model: CFL-10/ UFL-60

Classification: 2 Product Code: GEX Regulation Number: 21 CFR 878.4810 Review Panel: 878 General and Plastic Surgery

Intended Use Statement:

The equipment is used for human tissue vaporization. coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology,

{1}------------------------------------------------

K110434 Page (2) of

Section III 510(k) Summary

US agent

U.S. Agent Contact Name WEI HUANG

U.S. Agent Business Name MID-LINK INTERNATIONAL, INC.

U.S. Agent Full Address 307 EAGLE HEIGHTS APT E, MADISON, WISCONSIN, 53705, UNITED STATES

U.S. Agent E-mail info@mid-link.net

U.S. Agent Phone Number 608 -3355979

U.S. Agent Fax Number 760 -4665084

Predicate Device Identification

510(k) Number: K101555 Product Name: CO2 LASER SYSTEM Manufacturer: ADVANCED TECHNOLOGY LASER CO., LTD.

7. Device Description

The equipment is mainly used for human tissue vaporization, coagulation and exposure to achieve the purpose of treatment.

CFL-10 Trixel CO2 Laser:

The equipment includes the following:

One mainframe;

One footswitch; One data cable;

One power wire;

One ventilation tube;

Six Wire clips;

Two keys:

One trixel (bitmap) scanner handpiece;

Two trixel laser position heads

One ordinary treatment handpiece with aimed light

A laser goggles;

Three 3.15A fuses;

One user manual.

UFL-60 Trixel II CO2 Laser:

The equipment includes the following:

One mainframe;

{2}------------------------------------------------

Premarket Notification 510(k) Submission

Section III 510(k) Summary

One set of footswitch; One data cable; One power wire: One ventilation tube; Six Wire clip; Two keys; One trixel (bitmap) scanner handpiece; Three trixel laser position heads; One ordinary treatment handpiece with aimed light A laser goggles; Three SA fuses; One user manual.

8. Non-Clinical Test Conclusion

Bench 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 60825-1: 2007, Safety of laser products Part 1: Equipment classification, requirements. .
. 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 - Partl: 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.

Substantially Equivalent Conclusion 9.

The proposed device, Trixel CO2 Laser/Trixel H CO2 Laser, has same Product Code, Regulation Number. Class. Maximum Power. Work Mode. Wavelength. Mode Structure, Spot Size, Pulse Setting, etc., but only different in five aspects as following:

… Intended Use
1. Light Arm
1. Aiming Beam
1. Cooling System
న్న Power Input

For these different, we have performed analysis as following:

Analysis 1 the intended use of predicate device includes the one of proposed device. They both have the function of vaporization and coagulation. The above clearance for intended use does not introduce any problems regarding the safety and effectiveness of the device.

{3}------------------------------------------------

Avalysis 2: though the length of light arm is different. CFL-10: 0.97m. UFL-60: 1.17m, predicate device: 1.3m. it doesn't affect the treatment itself. This difference does not introduce any problems regarding the safety and effectiveness of the device.

See analysis 3: Both the output range of aiming beam is <SmW. which complies with the requirement of IEC 60601-2-22:2007. This difference does not introduce any problems regarding the safety and effectiveness of the device.

Analysis 4: air cooling system and water cooling system can both cool down the system. This difference does not introduce any problems regarding the safety and effectiveness of the device, they both comply with the requirement of IEC 60601-1.

Analysis 3: they have the similar power input, CF1,-10 Trixel CO2 Laser: - 120 V. UFL-60 Trixel II CO2 Laser: 120 V. predicate device: 115V. This difference does not introduce any problems regarding the safety and effectiveness of the device.

Basic on analysis above, proposed device has determined to be Substantially Equivalent (SE) to the predicate device, eBeam CQ2Laser System (K101555), in respect of safety and effectiveness.

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular text element and a stylized graphic of an eagle. The text element reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion. To the right of the text is a stylized graphic of an eagle with its wings spread.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

APR 1 9 2011

Beijing Syntech Laser Co., Ltd % Underwriters Laboratories, Inc. Mr. Marc M. Mouser 2600 NW Lake Road Camas, Washington 98607-9526

Re: K110434

Trade/Device Name: Trixel CO2 Laser/Trixel II CO2 Laser 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: March 28, 2011 Received: April 4, 2011

Dear Mr. Mouser:

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

{5}------------------------------------------------

Page 2 - Mr. Dennis Hahn, RAC

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.html 15809.html fast the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.html 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 no (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

AS B- nh

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

Enclosure

{6}------------------------------------------------

Section II Indications for Use

510(k) Number: Device Name: Trixel CO2 Laser/Trixel II CO2 Laser

Indications for Use:

The equipment is used for human tissue vaporization in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology,

�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 ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Neitke Ogiden for mxm

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K110434

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.