(92 days)
CO2 Laser System is used for human tissue vaporization, coagulation in dermatoloty and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.
CO2 Laser System is a laser beam generated by electrically excited carbon dioxide gas molecules, which has a very small divergence angle and high energy density. After focusing, it can reach a power of several kilowatts per square centimeter for vaporization. The unfocused original light beam irradiates the lesion tissue, which can cause coagulation of biological tissue. The CO2 laser penetrates the tissue deeper, and after irradiation, it can heat and treat the deep tissue.
This 510(k) clearance letter is for a CO2 Laser System (CO2 Laser SST-L23), a physical medical device, not an AI/ML-driven software device. The provided text outlines the substantial equivalence claims based on technical specifications and safety standards, rather than performance metrics from a clinical study involving AI. Therefore, most of the requested information regarding acceptance criteria for AI performance, sample sizes for test sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment is not applicable to this device and its clearance process.
The clearance relies on demonstrating that the device is substantially equivalent to a predicate device (K200042) in terms of its intended use, design, performance characteristics (e.g., maximum power, wavelength), and safety standards.
Here's a breakdown of the relevant information provided in the document:
1. A table of acceptance criteria and the reported device performance
For a physical device like a CO2 Laser, acceptance criteria are typically compliance with industry standards, performance specifications matching or being equivalent to a predicate device, and safety. The reported device performance is presented as a direct comparison to the predicate.
| Item | Acceptance Criteria (from Predicate Device K200042) | Reported Device Performance (CO2 Laser SST-L23) | Conclusion |
|---|---|---|---|
| Maximum Power | 30W | 30W | SE |
| Work Mode | Surgery (Single Pulse, Continuous, Pulse) | Surgery (Single Pulse, Continuous, Pulse) | SE |
| Wavelength | 10.6 um | 10.6 um | SE |
| Beam Delivery | 7 joint light guide arm | 7 joint light guide arm | SE |
| Aiming Beam | Red indicator light (650nm, ≤5 mW) | Red indicator light (650nm, ≤5 mW) | SE |
| Spot Size | 0.5 mm | 0.5 mm | SE |
| Output Power | pulse 1-30W, single 1-30W, continuous 1-30W | pulse 1-30W, single 1-30W, continuous 1-30W | SE |
| Pulse Duration | Single Pulse Mode: 1-1000 ms, Pulse mode: 1-1000 ms | Single Pulse Mode: 1-1000 ms, Pulse mode: 1-1000 ms | SE |
| Control System | Touch screen, footswitch | Touch screen, footswitch | SE |
| Laser Operation | Footswitch | Footswitch | SE |
| Laser medium/energy source | CO2 | CO2 | SE |
| Cooling System | Closed inner circulating water cooling | Air cooling | Similar (Analysis: "will not affect safety and effectiveness") |
| Cleaning Method | 70% isopropyl alcohol | 70% isopropyl alcohol | SE |
| Electrical Safety | Comply with IEC 60601-1, IEC 60601-2-22 | Comply with IEC 60601-1, IEC 60601-2-22 | SE |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | SE |
| Laser Safety | Comply with IEC 60601-2-22, IEC 60825-1 | Comply with IEC 60601-2-22, IEC 60825-1 | SE |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets acceptance criteria is described as Non-Clinical Testing.
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable in the context of an AI/ML test set. The evaluation is based on engineering specifications and compliance with standards.
- Data Provenance: Not applicable for a non-AI hardware device that relies on engineering testing and comparison to predicate specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable as this is a physical laser device, not an AI system requiring ground truth from experts for diagnostic or similar performance. The "ground truth" here is compliance with engineering standards and performance specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
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. This device is a surgical laser, not a diagnostic AI tool that would assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm, but a physical device. Its performance is evaluated intrinsically against its specifications and safety standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the context of AI. The "ground truth" for this device's performance relies on engineering measurements, material properties, electrical safety tests, laser safety tests, and biological compatibility tests, all benchmarked against established international standards (e.g., IEC, ISO). The comparison to the predicate device serves as the primary "ground truth" for substantial equivalence.
8. The sample size for the training set
- Not applicable. This device does not use a training set as it is not an AI/ML system.
9. How the ground truth for the training set was established
- Not applicable.
Summary of the Evaluation and "Study":
The "study" proving the device meets acceptance criteria is a series of non-clinical tests (engineering tests) and a comparison study to a legally marketed predicate device (K200042).
- Non-Clinical Tests Conducted:
- Electrical Safety: Compliance with IEC 60601-1 (Edition 3.2 2020-08)
- Laser Safety: Compliance with IEC 60825-1:2014 and IEC 60601-2-22:2012
- Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1-2 (Edition 4.1 2020-09)
- Biocompatibility (if applicable to contact parts): Compliance with ISO 10993-10 (skin sensitization), ISO 10993-23 (irritation), and ISO 10993-5 (in vitro cytotoxicity).
- Predicate Comparison: The performance and safety characteristics of the proposed device are directly compared feature-by-feature to the cleared predicate device. Differences (e.g., cooling system, dimensions, weight) are analyzed to ensure they do not negatively affect safety or effectiveness.
In conclusion, the clearance of the CO2 Laser System (CO2 Laser SST-L23) through K250183 is based on demonstrating substantial equivalence to a predicate device and compliance with relevant safety and performance standards for physical medical devices, not on data science criteria applicable to AI/ML systems.
FDA 510(k) Clearance Letter - CO2 Laser System
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID# 04017.07.05
Silver Spring, MD 20993
www.fda.gov
April 24, 2025
Zhuozhou Summer Star Technologies Co., Ltd
℅ Ray Wang
General Manager
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd.
FangShan District
Beijing, 102401
China
Re: K250183
Trade/Device Name: CO2 Laser System (CO2 Laser SST-L23)
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: January 22, 2025
Received: January 22, 2025
Dear Ray Wang:
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
Page 2
K250183 - Ray Wang Page 2
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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 (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-reporting-combination-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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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
Page 3
K250183 - Ray Wang Page 3
the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-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,
TANISHA L. HITHE -S
Digitally signed by TANISHA L. HITHE -S
Date: 2025.04.24 19:23:43 -04'00'
Tanisha Hithe
Assistant Director
DHT4A: Division of General Surgery Devices
OHT4: Office of Surgical and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known)
K250183
Device Name
CO2 Laser System (CO2 Laser SST-L23)
Indications for Use (Describe)
CO2 Laser System is used for human tissue vaporization, coagulation in dermatoloty and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Page 5
510(k) Summary
The assigned 510(k) Number: K250183
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 Title 21, CFR Section 807.92.
-
Date of Preparation: 2025.01.22
-
Sponsor Identification
Zhuozhou Summer Star Technologies Co.,Ltd
No. 502, building 2, junheyungu industrial park, Zhuozhou, Baoding, Hebei province, China
Contact Person: Lei Yan
Position: General Manager
Tel: +86- 13693100103
Email: 946280852@qq.com
- Designated Submission Correspondent
Mr. Ray Wang
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, 102401, China
Tel: +86-18910677558
Fax: +86-10-56335780
Email: information@believe-med.com
Page 6
- Identification of Proposed Device
Trade Name: CO2 Laser System
Common Name: Powered Laser Surgical Instrument
Regulatory Information
Classification Name: Powered Laser Surgical Instrument
Classification: II
Product Code: GEX
Regulation Number: 878.4810
Review Panel: General & Plastic Surgery
- Identification of Predicate Device(s)
510(k) Number: K200042
Product Name: CO2 Laser System
Manufacturer: Beijing Superlaser Technology Co., Ltd.
- Device Description
CO2 Laser System is a laser beam generated by electrically excited carbon dioxide gas molecules, which has a very small divergence angle and high energy density. After focusing, it can reach a power of several kilowatts per square centimeter for vaporization. The unfocused original light beam irradiates the lesion tissue, which can cause coagulation of biological tissue. The CO2 laser penetrates the tissue deeper, and after irradiation, it can heat and treat the deep tissue.
- Indication For Use Statement:
CO2 Laser System is used for human tissue vaporization, coagulation in dermatoloty and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.
Page 7
- Substantially Equivalent (SE) Comparison
Tab 1 General Comparison
| Item | Proposed Device | Predicate Device (K200042) | Remark |
|---|---|---|---|
| Product Code | GEX | GEX | SE |
| Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 | SE |
| Class | 2 | 2 | SE |
| Where used | hospital | hospital | SE |
| Intended Use | The CO2 Laser System is used for human tissue vaporization,coagulation in dermatoloty and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology. | The CO2 Laser System is used for human tissue vaporization,coagulation in dermatoloty and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology. | SE |
Tab 2 Performance Comparison
| Item | Proposed Device | Predicate Device (K200042) | Remark |
|---|---|---|---|
| Maximum Power | 30W | 30W | SE |
| Work Mode | Surgery (Single Pulse, Continuous, Pulse) | Surgery (Single Pulse, Continuous, Pulse) | SE |
| Wavelength | 10.6 um | 10.6 um | SE |
| Beam Delivery | 7 joint light guide arm | 7 joint light guide arm | SE |
| Aiming Beam | Red indicator light (650nm, ≤5 mW) | Red indicator light (650nm, ≤5 mW) | SE |
| Spot Sizer | 0.5 mm | 0.5 mm | SE |
| Output Power | pulse 1-30Wsingle 1-30Wcontinuous 1-30W | pulse 1-30Wsingle 1-30Wcontinuous 1-30W | SE |
| Pulse Duration | Single Pulse Mode: 1-1000 msPulse mode: 1-1000 ms | Single Pulse Mode: 1-1000 msPulse mode: 1-1000 ms | SE |
| Control System | Touch screen, footswitch | Touch screen, footswitch | SE |
| Laser Operation | Footswitch | Footswitch | SE |
| Laser medium/energy source | CO2 | CO2 | SE |
| Cooling System | Air cooling | Closed inner circulating water cooling | Similar |
| Cleaning Method | 70% isopropyl alcohol | 70% isopropyl alcohol | SE |
| Dimension | 39cm45cm117cm | 37.5 cm x 29 cm x 113 cm | Analysis |
| Weight | 44.83Kg | 40kg | Analysis |
| Power input | AC 110V 60Hz | 110V 60Hz or 230V 50Hz | SE |
Page 8
Tab 3 Safety Comparison
| Item | Proposed Device | Predicate Device K161925 | Remark |
|---|---|---|---|
| EMC, Electrical and Laser Safety | |||
| Electrical Safety | Comply with IEC 60601-1, IEC 60601-2-22 | Comply with IEC 60601-1, IEC 60601-2-22 | SE |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | SE |
| Laser Safety | Comply with IEC 60601-2-22, IEC 60825-1 | Comply with IEC 60601-2-22, IEC 60825-1 | SE |
Analysis
The difference between proposed device and predicate device lies in the appearance(dimension, weight). The difference will not affect the safety and effectiveness of proposed device in comparison to the predicate.
- 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 Edition 3.2 2020-08, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60825-1:2014, Safety of laser products - Part 1: Equipment classification, and requirements
- IEC 60601-2-22: 2012 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
- ISO 10993-10 Fourth edition 2021, Biological evaluation of medical devices - Part 10: Tests for skin sensitization
- ISO 10993-23 First edition 2021-01, Biological evaluation of medical devices - Part 23: Tests for irritation
- ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
- IEC 60601-1-2 Edition 4.1 2020-09, Medical Electrical Equipment-Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility-Requirements And Test
Page 9
- Clinical Test Conclusion
No clinical study is included in this submission.
- Conclusion
Based on the nonclinical tests performed, the subject device is as safe, as effective, and performance as well as the legally marketed predicate device, CO2 Laser System cleared under K200042.
§ 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.