(124 days)
Not Found
No
The description focuses on the physical properties and operation of a CO2 laser, and there is no mention of AI, ML, image processing, or data-driven decision making. The performance studies rely on non-clinical testing against standards and predicate devices.
Yes
The "Intended Use" explicitly states that the device is "used for body soft tissue ablation, vaporization, excision and coagulation in dermatology, plastic surgery and general surgery," which describes therapeutic applications. Additionally, the "Device Description" mentions that "treatment effect can be achieved," further supporting its therapeutic nature.
No
The device description states its use for "body soft tissue ablation, vaporization, excision and coagulation," indicating therapeutic rather than diagnostic functions.
No
The device description explicitly states it is a "CO2 Laser Therapy Systems" which involves a physical laser beam and its interaction with tissue, indicating a hardware component. The performance studies also reference standards related to electrical and laser equipment safety (IEC 60601 series, IEC 60825-1), further confirming it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used for "body soft tissue ablation, vaporization, excision and coagulation." These are surgical and therapeutic procedures performed directly on the patient's body.
- Device Description: The description details how the laser interacts with biological tissue through photo-induced solidification and vaporization. This is a physical interaction with living tissue, not an analysis of samples taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVD devices are designed to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
The device is a surgical/therapeutic laser system, not a diagnostic tool that analyzes samples.
N/A
Intended Use / Indications for Use
The CO2 Laser Therapy Systems is used for body soft tissue ablation, vaporization, excision and coagulation in dermatology, plastic surgery and general surgery.
Product codes
GEX
Device Description
CO2 Laser Therapy Systems is monochromatic light with strong penetration and precise focusing; When a continuous laser beam with a certain energy irradiates biological tissue, the instantaneous high temperature causes photo induced solidification and photo induced vaporization to irradiated tissue.iradiates biological tissue, the instantane causes photo induced solidification and photo induced vaporization to irradiaed tissue. With modulation pulse mode of CO2 laser, treatment effect can be achieved by control of laser emission frequency. After chosing laser Power, despite the frequency of laser emission, the laser is continuously output at a fixed Interval Time of 1 ms. Changes in frect interval time.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
All nonclinical testing performed on new devices is to demonstrate to the predicate devices. Tests setup and execution are performed in accordance with applicable standards. Results of the standards and matching the performance of new devices to the predicate devices. The following performance data were provided in support of the substantial equivalence determination.
- IEC 60601-1: Edition 3.2 2020-08 Medical electrical device Part !: General requirements for basic safety and essential performance
- IEC 60601-1-2: Edition 4.1 2020-09 Medical electrical equirements for basic safety and essential performance-Collateral standard: Electromagnetic compatibility- Requirements and tests
- IEC 60601-2-22: Edition 3.1 2012-10 Medical electrical equipments for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
- IEC/TR 60601-4-2:2016 Medical electrical equipment - Par4.2: Guidance and interpretation - electromance of medical electrical equipment and medical electrical systems
- IEC 60825-1: Edition 2.0 2007-03 Safety of laser products -Part 1: Equipment classification and requirements
- ISO 10993-5: Third Edition 2009-06-01Biological evaluation of medical devices -- Part 5: Tests: for In Vitro cytotoxicity
- ISO 10993-10: Fourth Edition 2021-11 Biological evaluation of medical devices Part 10: Tests for irritation and delayed-type hypersensitivity
- ISO 10993-23: First Edition 2021-01 Biological evaluation of medical devices Part 23: Tes:ts for irritation
No clinical study is included in this submission. The device mentioned above and passed the test results. Based on the noncinical tests performed , the subject device is as effective, and performance as well as the legally marketed predicate devices, cleared under K241670 and K161925.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image shows the date January 27, 2025. The month is January, the day is 27, and the year is 2025. The date is written in a clear, legible font. The text is black on a white background.
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Beijing Sano Laser S&T Development Co., Ltd. % Owen He Consultant Microkn Medical Technology Service(Shanghai) Co.,Ltd Company Room 901, Huafa Center, 889 Pinglu Road, Jing 'an District Shanghai. 200040 China
Re: K242941
Trade/Device Name: CO2 Laser Therapy Systems (SHE-LSP003-1) 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: December 31, 2024 Received: December 31, 2024
Dear Owen He:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
2
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Tanisha Hithe
Assistant Director
DHT4A: Division of General Surgery Devices
OHT4: Office of Surgical and
Infection Control Devices
YAN FU - Digitally signed
S by YAN FU -S
Date: 2025.01.27
11:34:46 -05'00'
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
CO2 Laser Therapy Systems (SHE-LSP003-1)
Indications for Use (Describe)
The CO2 Laser Therapy Systems is used for body soft tissue ablation, vaporization, excision and coagulation in dermatology, plastic surgery and general surgery.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
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510(k) #: K242941
510(k) Summary
Prepared on: 2025-01-24
Contact Details
21 CFR 807.92(a)(1)
| Applicant Name | Beijing Sano Laser S&T Development Co., Ltd |
|---|---|
| Applicant Address | Room 201, 2nd Floor, No.7 Building, Maohuagongchang, NO.1 CAIDA Third Street, Nancai Town, Shunyi District, Beijing, China Beijing 101300 China |
| Applicant Contact Telephone | +861360111308 |
| Applicant Contact | Li Zhengrong |
| Applicant Contact Email | 2881494815@qq.com |
| Correspondent Name | Microkn Medical Technology Service (Shanghai) Co.,LtdCompany |
| Correspondent Address | Room 901, Huafa Center, 889 Pinglu Road, Jing 'an District, Shanghai Shanghai 200040 China |
| Correspondent Contact Telephone | +86 17721293816 |
| Correspondent Contact | Mr. Owen He |
| Correspondent Contact Email | fda@microkn.com |
21 CFR 807.92(a)(2)
| Device Trade Name | CO2 Laser Therapy Systems (SHE-LSP003-1) |
|---|---|
| Common Name | Laser surgical instrument for use in general and plastic surgery and in dermatology |
| Classification Name | Powered Laser Surgical Instrument |
| Regulation Number | 878.4810 |
| Product Code(s) | GEX |
21 CFR 807.92(a)(3)
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K161925 | CO2 Laser Therapy Machine | GEX |
| K241670 | Fractional CO2 Laser Therapy System | GEX |
21 CFR 807.92(a)(4)
CO2 Laser Therapy Systems is monochromatic light with strong penetration and precise focusing; When a continuous laser beam with a certain energy irradiates biological tissue, the instantaneous high temperature causes photo induced solidification and photo induced vaporization to irradiated tissue.iradiates biological tissue, the instantane causes photo induced solidification and photo induced vaporization to irradiaed tissue. With modulation pulse mode of CO2 laser, treatment effect can be achieved by control of laser emission frequency. After chosing laser Power, despite the frequency of laser emission, the laser is continuously output at a fixed Interval Time of 1 ms. Changes in frect interval time.
5
Intended Use/Indications for Use
The CO2 Laser Therapy Systems is used for body soft tissue ablation, vaporization in dermatology, plastic surgery and general surgery.
Indications for Use Comparison
The indication for use is the same with predicate device K241670.
Technological Comparison
We chose Kl61925 (CO2 Laser Therapy Machine) as the equivalent product in the normal mode. At the same time, K241670 (Fractional CO2 Laser Therapy System) is selected as the equivalent device in Fractional mode.
In Normal Mode. the subject device has the same technical che redicate device K161925 in wavelength, laser type, laser classification, pulse width range and frequency. In Fractional mode, the subject device's parameters (density/spot range is within the range of predicate device K241670. There is minor difference in pulse width range (0.19.9ms vs. 0.12.6ms).
However, such differences will not affectiveness of this product, and we have also made a detailed and accurate analysis of this in the Substantial Equivalence Discussion in the dithough there are slight differences in this product, However, all omply with the requirements of IEC 60601-1, IEC 60601-2-22, IEC 60601-1-2 and IEC/TR 60601-4-2.
The proposed device is as safe and effective as a legally marketed predicate device, and does not raise new safety or effectiveness issues, and the proposed device is substantially equivalent to the predicate device.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
All nonclinical testing performed on new devices is to demonstrate to the predicate devices. Tests setup and execution are performed in accordance with applicable standards. Results of the standards and matching the performance of new devices to the predicate devices. The following performance data were provided in support of the substantial equivalence determination.
- IEC 60601-1: Edition 3.2 2020-08 Medical electrical device Part !: General requirements for basic safety and essential performance
- · IEC 60601-1-2: Edition 4.1 2020-09 Medical electrical equirements for basic safety and essential performance-Collateral standard: Electromagnetic compatibility- Requirements and tests
· IEC 60601-2-22: Edition 3.1 2012-10 Medical electrical equipments for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
· IEC/TR 60601-4-2:2016 Medical electrical equipment - Par4.2: Guidance and interpretation - electromance of medical electrical equipment and medical electrical systems
· IEC 60825-1: Edition 2.0 2007-03 Safety of laser products -Part 1: Equipment classification and requirements
- · ISO 10993-5: Third Edition 2009-06-01Biological evaluation of medical devices -- Part 5: Tests: for In Vitro cytotoxicity
- ISO 10993-10: Fourth Edition 2021-11 Biological evaluation of medical devices Part 10: Tests for irritation and delayed-type hypersensitivity
- ISO 10993-23: First Edition 2021-01 Biological evaluation of medical devices Part 23: Tes:ts for irritation
No clinical study is included in this submission. The device mentioned above and passed the test results. Based on the noncinical tests performed , the subject device is as effective, and performance as well as the legally marketed predicate devices, cleared under K241670 and K161925.
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)