(90 days)
Not Found
No.
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description does not include any components or functionalities that suggest the presence of an AI model.
Yes.
The device is used for incision, excision, ablation, vaporization, and coagulation of body soft tissues, which are therapeutic interventions. Additionally, it explicitly mentions "therapeutic" in one of the standards met: 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.
No
The device description and intended use clearly state that this is a therapeutic device used for "ablative skin resurfacing," "incision, excision, ablation, vaporization and coagulation of body soft tissues." It does not describe any function related to diagnosing a disease or condition.
No
The device description explicitly details a physical CO2 laser machine with hardware components like a control display panel, main control power module, light guide arm module, fan cooling module, and laser module. The intended use involves physical interaction with body tissues (ablation, incision, etc.) which is characteristic of a hardware-based medical device.
No.
The device is a CO2 laser used for surgical and aesthetic procedures, which are in vivo applications. It does not perform tests on samples taken from the human body for diagnostic purposes.
N/A
Intended Use / Indications for Use
- CO2 LASER Part:
Fractional mode is indicated only for ablative skin resurfacing.
Non-fractional mode (Impulse mode) is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otorhinolaryngology (ENT), gynecology, neurosurgery, dental and oral surgery and genitourinary surgery.
Product codes
GEX, ONG
Device Description
The Fractional CO2 Laser Machine uses a CO2 laser with the emission wavelength of 10600nm to emit focal spots through a high focus lens. The target is water in skin tissue. A certain amount of thermal stripping, more thermal coagulation and obvious thermal effect are produced at the part directly penetrated by the focal spot.
The Fractional CO2 Laser Machine has two operational modes, fractional mode and impulse mode.
- Fractional mode includes three modes: normal, random and midsplit;
- Impulse mode includes three modes: single, continuous and impulse.
The Fractional CO2 Laser Machine has 5 modules: Control display panel module, Main control power module, Light guide arm module, Fan cooling module, Laser module.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body soft tissues including intraoral tissues
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical specialties including aesthetic (dermatology and plastic surgery), otorhinolaryngology (ENT), gynecology, neurosurgery, dental and oral surgery and genitourinary surgery.
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)
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 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 Tests
- 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 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
- 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
FDA 510(k) Clearance Letter - Fractional CO2 Laser Machine
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
June 12, 2025
Zhengzhou PZ Laser Slim Technology 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: K250782
Trade/Device Name: Fractional CO2 Laser Machine
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, ONG
Dated: March 14, 2025
Received: March 14, 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 Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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K250782 - Ray Wang Page 2
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 the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
Page 3
K250782 - Ray Wang Page 3
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: 2025.06.12 12:12:20 -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
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.
Submission Number (if known): K250782
Device Name: Fractional CO2 Laser Machine
Indications for Use (Describe)
- CO2 LASER Part:
Fractional mode is indicated only for ablative skin resurfacing.
Non-fractional mode (Impulse mode) is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otorhinolaryngology (ENT), gynecology, neurosurgery, dental and oral surgery and genitourinary 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.
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: K250782
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.
1. Date of Preparation: 2025/02/25
2. Sponsor Identification
Zhengzhou PZ Laser Slim Technology Co., Ltd.
Room 201, 2nd Floor, Building 2, No. 52 Hongsong Road, High-tech Development Zone, 450001, Zhengzhou City, Henan Province, P.R.China
Contact Person: Hongwei Zhou
Position: General Manager
Tel: +86-18736013788
Fax: 0371-55677868
Email: 565107678@qq.com
3. 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
Email: information@believe-med.com
Page 6
510(k) Summary
4. Identification of Proposed Device
Trade Name: Fractional CO2 Laser Machine
Common Name: Powered Laser Surgical Instrument, Powered Laser Surgical Instrument With Microbeam\Fractional Output
Regulatory Information
Classification Name: Powered Laser Surgical Instrument, Powered Laser Surgical Instrument With Microbeam\Fractional Output
Classification: II
Product Code: GEX, ONG
Regulation Number: 878.4810
Review Panel: General & Plastic Surgery
5. Identification of Predicate Device(s)
510(k) Number: K172096
Product Name: Ilooda Fraxis CO2 Laser
Manufacturer: Ilooda Co. LTD
6. Device Description
The Fractional CO2 Laser Machine uses a CO2 laser with the emission wavelength of 10600nm to emit focal spots through a high focus lens. The target is water in skin tissue. A certain amount of thermal stripping, more thermal coagulation and obvious thermal effect are produced at the part directly penetrated by the focal spot.
The Fractional CO2 Laser Machine has two operational modes, fractional mode and impulse mode.
- Fractional mode includes three modes: normal, random and midsplit;
- Impulse mode includes three modes: single, continuous and impulse.
The Fractional CO2 Laser Machine has 5 modules: Control display panel module, Main control power module, Light guide arm module, Fan cooling module, Laser module.
7. Indication For Use Statement:
- CO2 LASER Part:
Fractional mode is indicated only for ablative skin resurfacing.
Non-fractional mode (Impulse mode) is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otorhinolaryngology (ENT), gynecology, neurosurgery, dental and oral surgery and genitourinary surgery.
Page 7
510(k) Summary
8. Substantially Equivalent (SE) Comparison
Tab 1 General Comparison
| Item | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| Device Name | Fractional CO2 Laser Machine | Ilooda Fraxis CO2 Laser | / |
| Classification Regulation | 21 CFR 878.4810 | 21 CFR 878.4810 | SAME |
| Classification Panel | General & Plastic Surgery | General & Plastic Surgery | SAME |
| Class | II | II | SAME |
| Product Code | GEX, ONG | GEX, ONG | SAME |
| Common Name | Powered Laser Surgical Instrument, Powered Laser Surgical Instrument With Microbeam\Fractional Output | Powered Laser Surgical Instrument, Powered Laser Surgical Instrument With Microbeam\Fractional Output | SAME |
| Indication for use | - CO2 LASER Part: Fractional mode is indicated only for ablative skin resurfacing. Non-fractional mode (Impulse mode) is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otorhinolaryngology (ENT), gynecology, neurosurgery, dental and oral surgery and genitourinary surgery. | - CO2 LASER Part: Fractional mode is indicated only for ablative skin resurfacing. Non-fractional mode is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otorhinolaryngology (ENT), gynecology, neurosurgery, dental and oral surgery and genitourinary surgery. | SAME |
| Prescription use or not | Prescription use | Prescription use | SAME |
Tab 2 Performance Comparison
| ITEM | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| Laser Type | CO2 | CO2 | SAME |
| Laser Wavelength | 10.6μm | 10.6μm | SAME |
| Output power | 30W | 30W | SAME |
Page 8
510(k) Summary
| Pulse Duration | 100-5,000μs | 20-5,000μs | SAME |
| Fractional Pulse energy | Max 150mJ | Max 150mJ | SAME |
| Repetition rate | 1,000Hz | 1,000Hz | SAME |
| Scan area | 20x20mm | 20x20mm | SAME |
| Spot size | 100-200μm Non-fractional: Max 1.3mm | 100-200μm Non-fractional: Max 1.3mm | SAME |
| Number of microbeams per surface area (fractional) | Max 289 spot/cm2 | Max 289 spot/cm2 | SAME |
| Energy per microbeam (fractional) | 150mJ | 150mJ | SAME |
| Total power per surfaced area (fractional) | Max 30W | Max 30W | SAME |
| Treatment Time | 10-15 min | 10-15 min | SAME |
| Pulse rate (nonfractional) | 1Hz – 1,000Hz | 1Hz – 1,000Hz | SAME |
| Pulse width (nonfractional) | 100μs –5000μs | 20μs –5000μs | SAME |
| Operational mode | Fractional mode, Impulse mode (single/ continuous/ impulse) | Fractional mode, normal mode (CW, Pulse, Single Pulse) | SAME |
| Aiming beam | Diode laser (Red), Max 4mW | Diode laser(Red), Max 4mW | SAME |
| Cooling | Air cooling | Air cooling | SAME |
| User Interface | LCD touch screen | LCD touch screen | SAME |
| Optical guide | Articulate system | Articulated arm | SAME |
| Electrical Requirements | 100-120V~, 50-60Hz | 100-240VAC, 50-60 Hz, 6.3 A | Analysis |
| Energy flux per μ beams(mJ/cm2/pulse, mean and range) | (4.810^51.910^6) mJ/cm2 | (4.810^51.910^6) mJ/cm2 | SAME |
| Power flux per μbeam(mW/cm2/ pulse, mean and range) | (9.510^73.810^8)mW/cm2 | (9.510^73.810^8)mW/cm2 | SAME |
| Inter-beam spacing(mm, mean and range) | 0.6mm-2.6mm | / | Analysis |
Page 9
510(k) Summary
Analysis:
Analysis- Electrical Requirements
The electrical requirements for the proposed device is different from the predicate device. However, electrical safety and EMC test has been conducted on the proposed device and the test result show that the device can work normally under this electrical requirements. Therefore, this difference will not affect safety and effectiveness of the proposed device.
Analysis - Inter-beam spacing
In theory, the Inter-beam spacing is determined by the diameter of the micro beams and the number of micro beams per unit area (289 spot/cm2). And because the micro beam diameter and the number of micro beams per unit area (289 spots/cm2) of the subject device are exactly the same as the predicate
Page 10
510(k) Summary
device. Therefore, we believe that the Inter-beam spacing of the subject device should be the same as the predicate device.
Tab 3 Safety Comparison
| ITEM | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| Electrical Safety | Comply with IEC 60601-1 | Comply with IEC 60601-1 | SAME |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | SAME |
| Laser Safety | Comply with IEC 60601-2-22, IEC 60825-1 | Comply with IEC 60601-2-22, IEC 60825-1 | SAME |
Biocompatibility
| Cytotoxicity | No Cytotoxicity | No Cytotoxicity | SAME |
| Irritation | No evidence of irritation | No evidence of irritation | SAME |
| Sensitization | No evidence of sensitization | No evidence of sensitization | SAME |
9. 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 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 Tests
- 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 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
- 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
10. Clinical Test Conclusion
No clinical study is included in this submission.
11. 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, Ilooda Fraxis CO2 Laser cleared under K172096.