Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber (PT-OF-D-S); Laser Fiber (PT-OF-E-S); Laser Fiber (PT-OF-F-S)

K253007 · Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. · GEX · Nov 20, 2025 · General, Plastic Surgery

Device Facts

• Record ID: K253007
• Device Name: Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber (PT-OF-D-S); Laser Fiber (PT-OF-E-S); Laser Fiber (PT-OF-F-S)
• Applicant: Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Nov 20, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

PT-OF-X-S Series Laser Fiber (Models PT-OF-A-S, PT-OF-B-S, PT-OF-C-S, PT-OF-D-S, PT-OF-E-S, PT-OF-F-S) is indicated for to deliver laser energy from a source to the target tissue in laser surgery applications, when used with any cleared/certified laser with wavelengths 1940nm - 2100nm equipped with SMA 905 standard connector.

Device Story

Reusable optical fiber delivery system; transmits laser energy from external laser source to surgical site. Utilizes high-purity quartz glass core; total internal reflection principle. Features SMA-905 connector; integrated RFID module for usage tracking/cycle management (max 10 uses). Used in healthcare facilities by physicians; requires sterilization prior to use. Enables precise laser energy delivery for surgical procedures; benefits patient through controlled tissue interaction.

Clinical Evidence

Bench testing only. Includes optical performance (transmission efficiency, beam profile), mechanical testing (tensile strength, bend fatigue), and biocompatibility (ISO 10993-1, -10, -11, -23). Reusability validated for 10 cycles.

Technological Characteristics

Optical fiber with silica quartz core, hard clad, silicone, and ETFE materials. SMA-905 connector. Wavelength range 1940nm-2100nm. Reusable (up to 10 cycles). Integrated RFID module for usage tracking. Non-sterile supply; requires sterilization.

Indications for Use

Indicated for delivery of laser energy from a source to target tissue in surgical applications; for use with cleared/certified lasers (1940nm-2100nm) featuring SMA 905 connectors. Intended for professional use in healthcare facilities by physicians.

Regulatory Classification

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.

Predicate Devices

• LGO-Surgical Laser Fibers (K243147)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

November 20, 2025

Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.
Zhengzhou Li
General Manager
Room 208, Building C, No. 3, Juquan Road
Huangpu District
Guangzhou, Guangdong 510000
China

Re: K253007
Trade/Device Name: PT-OF-X-S Series Laser Fiber
(Models: PT-OF-A-S, PT-OF-B-S, PT-OF-C-S, PT-OF-D-S, PT-OF-E-S, PT-OF-F-S)
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: September 15, 2025
Received: September 19, 2025

Dear Zhengzhou Li:

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

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K253007 - Zhengzhou Li
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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

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K253007 - Zhengzhou Li
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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-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

TANISHA L. HITHE -S
Digitally signed by
TANISHA L. HITHE -S
Date: 2025.11.20
15:40:50 -05'00'

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

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FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K253007 | |
| Device Name PT-OF-X-S Series Laser Fiber (Models PT-OF-A-S, PT-OF-B-S, PT-OF-C-S, PT-OF-D-S, PT-OF-E-S, PT-OF-F-S) | |
| Indications for Use (Describe) PT-OF-X-S Series Laser Fiber (Models PT-OF-A-S, PT-OF-B-S, PT-OF-C-S, PT-OF-D-S, PT-OF-E-S, PT-OF-F-S) is indicated for to deliver laser energy from a source to the target tissue in laser surgery applications, when used with any cleared/certified laser with wavelengths 1940nm - 2100nm equipped with SMA 905 standard connector. | |
| 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 [e-mail] | |
| "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." | |

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510(k) SUMMARY K253007

- Submitter Information

| Field | Information |
| --- | --- |
| Submitter Name | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. |
| Address | Room 208, Building C, No. 3, Juquan Road, Huangpu District, Guangzhou, Guangdong Province,510000, China |
| Phone | [phone] |
| Fax | [phone] |
| Contact Person | Zhengzhou Li |
| Email | [e-mail] |
| Date Prepared | August 15, 2025 |

- Device Information

| Field | Information |
| --- | --- |
| Device Trade Name | PT-OF-X-S Series Laser Fiber
(Models: PT-OF-A-S, PT-OF-B-S, PT-OF-C-S, PT-OF-D-S, PT-OF-E-S, PT-OF-F-S) |
| Models | PT-OF-A-S, PT-OF-B-S, PT-OF-C-S, PT-OF-D-S, PT-OF-E-S, PT-OF-F-S |
| Common Name | Laser Powered Surgical Instrument |
| Regulation Name | Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology |
| Regulation Number | 21 CFR 878.4810 |
| Regulatory Class | Class II |
| Product Code | GEX |
| Panel | General and Plastic Surgery |

- Predicate Device

| Type | Device | Manufacturer | 510(k) Number |
| --- | --- | --- | --- |
| Primary Predicate | LGO-Surgical Laser Fibers | Light Guide Optics International Ltd. | K243147 |

- Device Description

The PT-OF-X-S Series Laser Fiber is a reusable (up to 10 uses) optical fiber delivery system designed to transmit laser energy from compatible laser sources to surgical treatment sites. The device utilizes high-purity quartz glass core technology with total internal reflection principles to deliver precise laser energy for various surgical applications.

The system features an SMA-905 standard connector for universal compatibility with cleared laser systems operating at wavelengths between 1940nm and 2100nm. Each fiber incorporates an integrated RFID module for usage tracking and cycle management, ensuring safe reuse within validated parameters.

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The device is supplied non-sterile and requires sterilization prior to use. It is designed for professional use in healthcare facilities by physicians familiar with laser surgical procedures.

- Indications for Use

PT-OF-X-S Series Laser Fiber (Models PT-OF-A-S, PT-OF-B-S, PT-OF-C-S, PT-OF-D-S, PT-OF-E-S, PT-OF-F-S) is indicated for to deliver laser energy from a source to the target tissue in laser surgery applications, when used with any cleared/certified laser with wavelengths 1940nm - 2100nm equipped with SMA 905 standard connector.

- Technological Characteristics Comparison

| Feature | Subject Device | Predicate Device | Comparison |
| --- | --- | --- | --- |
| Product name | PT-OF-X-S Series Laser Fiber | LGO- Surgical Laser Fibers | / |
| 510(k) number | K253007 | K243147 | / |
| Manufacturer | Potent Medical | Light Guide Optics International Ltd. | / |
| Product code | GEX | GEX | Identical |
| Intended Use | PT-OF-X-S Series Laser Fiber (Models PT-OF-A-S, PT-OF-B-S, PT-OF-C-S,PT-OF-D-S, PT-OF-E-S, PT-OF-F-S) is indicated for to deliver laser energy from a source to the target tissue in laser surgery applications, when used with any cleared/certified laser with wavelengths 1940nm - 2100nm equipped with SMA 905 standard connector. | LGO-Surgical Laser Fibers are intended to be used to deliver the laser radiation to the target tissue when used with any cleared/certified laser with Operational wavelengths between 500 nm - 2200 nm equipped with SMA 905 standard or freestanding ferrule connector, as per the indications of the laser device used with. | Substantial Equivalence |
| Wavelength Range | 1940nm - 2100nm | 500nm - 2200nm | Similar, narrower range |
| Core Diameter | 200μm - 1000μm | 145μm - 1000μm | Similar range |
| Connector Type | SMA-905 | SMA-905 | Identical |
| Construction Materials | Silica quartz, hard clad, silicone, ETFE | Silica quartz, hard clad, silicone, polyimide, nylon, ETFE | Identical |
| Fiber Length | 3 meters | Variable | Similar |
| Usage Type | Reusable (10x) | Single use or reusable (10x) | Same reuse capability |

- Performance Testing

Standards Conformance: The subject device was tested according to recognized consensus standards including:

ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process

ISO 10993-10: 2021 Biological evaluation of medical devices-Part 10: Tests for irritation and skin

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sensitization

ISO 10993-23:2021 Biological evaluation of medical devices—Part 23: Tests for irritation

ISO 10993-11: 2017 Biological evaluation of medical devices—Part 11: Tests for systemic toxicity

Non-Clinical Performance Testing: Comprehensive testing was conducted including:

- Optical Performance: Transmission efficiency, wavelength stability, beam profile analysis
- Mechanical Testing: Tensile strength, bend radius validation, bend fatigue test.
- Biocompatibility: Complete ISO 10993 evaluation for patient-contacting materials
- Reusability Testing: 10-cycle validation including mechanical and optical performance

All testing demonstrated that the device performs as intended and meets specified requirements.

- Substantial Equivalence Conclusion

The PT-OF-X-S Series Laser Fiber demonstrates substantial equivalence to the predicate device (K243147) based on the following:

Same Intended Use:

- Both devices deliver laser energy to target tissue for surgical applications
- Identical indications across multiple surgical specialties
- Same professional user population and clinical environment

Similar Technological Characteristics:

- Identical SMA-905 connector interface
- Same core construction materials and principles
- Equivalent optical transmission properties
- Similar mechanical performance specifications

Enhanced Features Without New Safety Concerns:

- RFID integration provides improved usage tracking capability

Performance Equivalence:

- Comprehensive non-clinical testing demonstrates equivalent performance
- Identical reuse validation parameters

Minor differences in wavelength range specification and RFID integration do not raise new questions of safety or effectiveness. The device operates within well-established technological parameters and provides equivalent clinical functionality to the predicate device.

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Based on the comparison of intended use, technological characteristics, and performance data, the PT-OF-X-S Series Laser Fiber is substantially equivalent to the identified predicate device.

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