Finexel

K213557 · SNJ Co., Ltd. · GEX · Apr 12, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K213557
• Device Name: Finexel
• Applicant: SNJ Co., Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Apr 12, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Finexel CO2 laser system is intended for use in non-fractionated mode for Incision, Ablation, Vaporization, and Coagulation of Human body soft Tissues in Dermatology, Plastic surgery, Gynecology, Neurosurgery, and in Podiatry.

Device Story

Finexel CO2 laser system; utilizes CO2 laser energy for surgical applications. Device performs incision, ablation, vaporization, and coagulation of soft tissues. Operated by clinicians in clinical settings (dermatology, plastic surgery, gynecology, neurosurgery, podiatry). System provides controlled laser energy delivery to target tissue; enables precise surgical intervention. Benefits include reduced bleeding and tissue trauma during procedures. Clinician controls parameters via system interface to achieve desired surgical outcome.

Clinical Evidence

Bench testing only.

Technological Characteristics

CO2 laser surgical system; non-fractionated mode; intended for soft tissue incision, ablation, vaporization, and coagulation. Class II device (21 CFR 878.4810, Product Code GEX).

Indications for Use

Indicated for incision, ablation, vaporization, and coagulation of human soft tissues in dermatology, plastic surgery, gynecology, neurosurgery, and podiatry. Prescription use only.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 12, 2022

SNJ Co., Ltd % Chi Young CEO Bio-Med USA, Inc 27 New England Dr Ramsey, New Jersey 07446

Re: K213557

Trade/Device Name: Finexel 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: February 1, 2022 Received: March 3, 2022

Dear Chi Young:

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. 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 located 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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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-regulatoryassistance/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.

Purva Pandya, D.Eng. 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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## Indications for Use

510(k) Number (if known) K213557

Device Name Finexel CO2 Laser System

Indications for Use (Describe)

Finexel CO2 laser system is intended for use in non-fractionated mode for Incision, Ablation, Vaporization, and Coagulation of Human body soft Tissues in Dermatology, Plastic surgery, Gynecology, Neurosurgery, and in Podiatry.

Type of Use (Select one or both, as applicable)

| <div> <input checked="true" type="checkbox"/> Description Use (Ref 21 CFR 606.3, subpart D) </div> |
|-----------------------------------------------------------------------------------------------------------|
| <div> <input type="checkbox"/> Own-Use Consumable (21 CFR 606.3, subpart J) </div> |

> Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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