(105 days)
Not Found
No
The description focuses on the physical components and laser technology, with no mention of AI or ML capabilities.
Yes
The device is used for "ablation, vaporization and coagulation," which are therapeutic procedures to treat body soft tissue.
No
The device description indicates that the CO2 Laser System is a surgical laser device used for "ablation, vaporization and coagulation," which are therapeutic actions, not diagnostic processes.
No
The device description clearly outlines hardware components such as a console, articulated arm, footswitch, laser tube, and handpieces, indicating it is a physical medical device, not software-only.
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 and coagulation in dermatology, plastic surgery and general surgery." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The description details a surgical laser system that delivers energy to tissue.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens (like blood, urine, tissue samples) outside of the body to provide information about a patient's health. This device does not perform any such analysis on specimens.
The device is a surgical laser system used for therapeutic purposes directly on the patient, which falls under the category of medical devices but not specifically IVDs.
N/A
Intended Use / Indications for Use
The CO2 Laser System is used for body soft tissue ablation, vaporization and coagulation in dermatology, plastic surgery and general surgery.
Product codes
GEX
Device Description
CO2 Laser System is a carbon dioxide surgical laser device intended for prescription use and is comprised mainly of three components: console, articulated arm and footswitch.CO2 Laser System contains a radio-frequency excited CO2 laser tube which generates laser sources at nominal wavelength of 10,600 nm. As CO2 laser radiation is invisible; therefore, a low-power, visible aiming laser source (650 mm) is required to position the treatment laser beam. The output of laser beam is delivered through articulated arm to a fractional handpiece or normal handpiece. The control panel is in the form of an LCD touch screen in front of device and displays for operating and monitoring the laser. The physician activates laser emission by means of a footswitch. The fractional handpiece is suited mainly for general surgical application.
When the laser contacts human tissue, the laser energy is absorbed by water in the target tissue, resulting in a very rapid, highly localized temperature increase to the tissue. The instantaneous temperature-increase heats up the water and causes evaporation of the affected tissue. Some heat is absorbed by tissue adjacent to the treatment area, causing tissue coagulation which induces hemostasis as well as thermal stimulation of deep skin layers, that inducing fibroblast stimulation and neocollagenesis.
The CO2 Laser System is capable of producing continuous-wave, pulsed laser or fractional laser radiation. The physician can optimize the parameter for different applications by adjusting the energy of laser pulse and output pattern.
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)
The CO2 Laser System has been determined through engineering testing to verify laser energy output and electrical safety. The test results demonstrated that the proposed device complies with IEC 60601-1: 2005+corr.1:2006+Corr.2.2007+A1:2012, IEC 60601-1-2:2014, IEC 60825-1:2014, and IEC 60601-2-22:2007(third edition)+A1:2012. Software verification and validation testing were conducted.
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.
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Image /page/0/Picture/0 description: The image contains 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 logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
September 15, 2022
Smedtrum Medical Technology Co., Ltd. Crimson Wu Senior Regulatory Engineer 1F., No. 8, Ln. 97, Wugong Rd., New Taipei City, Xinzhuang Dist. 248016 Taiwan
Re: K221597
Trade/Device Name: CO2 Laser System 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: August 3. 2022 Received: August 3, 2022
Dear Crimson Wu:
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.
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Jianting Wang Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221597
Device Name CO2 Laser System
Indications for Use (Describe)
The CO2 Laser System is used for body soft tissue ablation, vaporization and coagulation in dermatology, plastic surgery and general surgery.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image contains a logo for Smedtrum Medical Technology Co., Ltd. The logo features a stylized blue and teal geometric shape resembling a stylized letter "S" on the left. To the right of the shape is the company name, with "Smedtrum" in a larger, light blue font and "MEDICAL TECHNOLOGY CO., LTD." in a smaller, gray font below it. Above the company name is the Chinese translation of the company name in gray.
Smedtrum Medical Technology Co., Ltd. 1F., No. 8, Ln. 97, Wugong Rd., Xinzhuang Dist., New Taipei City 248016 , Taiwan TEL:+886 (02) 2298 9578 FAX:+886 (02) 2298 9426
Section 5 : 510(k) Summary CO2 Laser System (K221597)
I. SUBMITTER
Smedtrum Medical Technology Co., Ltd. 1F., No. 8, Ln. 97, Wugong Rd., Xinzhuang Dist., New Taipei City 248016, Taiwan (R.O.C.) Contact Person Crimson Wu Position: Senior Regulatory Engineer Tel: +886-2-2298-9578, Ext. 301 Fax: +886-2-2298-9426 E-mail: crimsonwu@smedtrum.com Date of preparation: May 31th, 2022
II. DEVICE
| Trade Name: | CO2 Laser System |
|---|---|
| Common or Usual Name: | Surgical Laser Device |
| Classification Name: | GEX-Powered Laser Surgical Instrument |
| 21 C.F.R. § 878.4810, Device Class II |
III. PREDICATE DEVICE
| Trade Name: | CO2 Laser Therapy System | ||
|---|---|---|---|
| Common or Usual Name: | Surgical Laser Device | ||
| Classification Name: | GEX-Powered Laser Surgical Instrument | ||
| 21 C.F.R. § 878.4810, Device Class II | |||
| Premarket Notification: | K201109 | Sep 15th, 2020 |
IV. DEVICE DESCRIPTION
CO2 Laser System is a carbon dioxide surgical laser device intended for prescription use and is comprised mainly of three components: console, articulated arm and footswitch.CO2 Laser System contains a radio-frequency excited CO2 laser tube which generates laser sources at nominal wavelength of 10,600 nm. As CO2 laser radiation is invisible; therefore, a low-power, visible aiming laser source (650 mm) is required to position the treatment laser beam. The output of laser beam is delivered through articulated arm to a fractional handpiece or normal handpiece. The control panel is in the form of an LCD touch screen in front of device and displays for operating and monitoring the laser. The physician activates laser emission by means of a footswitch. The fractional handpiece is suited mainly for general surgical application.
4
Image /page/4/Picture/0 description: The image contains a logo for a medical technology company. On the left side of the logo is a blue and gray geometric shape. To the right of the shape is the company name, "Smedtrum MEDICAL TECHNOLOGY CO.,LTD."
When the laser contacts human tissue, the laser energy is absorbed by water in the target tissue, resulting in a very rapid, highly localized temperature increase to the tissue. The instantaneous temperature-increase heats up the water and causes evaporation of the affected tissue. Some heat is absorbed by tissue adjacent to the treatment area, causing tissue coagulation which induces hemostasis as well as thermal stimulation of deep skin layers, that inducing fibroblast stimulation and neocollagenesis.
The CO2 Laser System is capable of producing continuous-wave, pulsed laser or fractional laser radiation. The physician can optimize the parameter for different applications by adjusting the energy of laser pulse and output pattern.
INDICATIONS FOR USE V.
The CO2 Laser System is used for body soft tissue ablation, vaporization, excision and coagulation in dermatology, plastic surgery and general surgery.
COMPARISON OF TECHNOLOGICAL CHARATERISTICS WITH THE VI.
| Feature | Proposed device | Predicate device
(K201109) |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | CO2 Laser System | CO2 Laser Therapy System |
| Product Code | GEX | GEX |
| Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 |
| Device Class | Class II | Class II |
| Indication for
Use | The CO2 Laser System is used
for body soft tissue ablation,
vaporization, excision and
coagulation in dermatology,
plastic surgery and general
surgery. | The CO2 Laser Therapy
System is used for body soft
tissue vaporization and
coagulation in dermatology and
plastic surgery, general surgery,
gynecology. |
| Laser Type | RF Sealed-off CO2 | RF Sealed-off CO2 |
| Laser
Classification | Class 4 | Class 4 |
| CO2 Laser
Wavelength | 10600 nm | 10600 nm |
| Aiming Beam
Wavelength |