(116 days)
Not Found
No
The summary describes a standard CO2 surgical laser system with no mention of AI or ML capabilities in its intended use, device description, or performance studies.
Yes
The device is described as a surgical laser system intended for medical specialties and procedures such as skin resurfacing, treatment of lesions, and various surgical applications.
No
This device is a surgical laser system designed for incision, ablation, vaporization, and coagulation of soft tissues, not for diagnosing medical conditions. Its described uses are all therapeutic or procedural.
No
The device description explicitly states it is a "CO2 Surgical laser System incorporating a permanently articulated arm that delivers CO2 laser power" and is activated by a footswitch. This clearly indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical laser system used for the incision, ablation, vaporization, and coagulation of body soft tissues. These are direct surgical procedures performed on a patient's body.
- Device Description: The device is described as a CO2 Surgical laser System that delivers laser power for surgical applications.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (on the body) for surgical treatment.
N/A
Intended Use / Indications for Use
It is indicated for incision, ablation, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology, neurosurgery, orthopaedics, general and thorasic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.
The CO2 System is intended for use in surgical applications requiring the ablation, vaporization, and coagulation of soft tissue in dermatology and plastic surgery, general surgery.
Dermatology, Plastic Surgery and General Surgery procedures:
- · Laser skin resurfacing.
- Treatment of furrows and wrinkles.
· Removal of skin tags, actinic keratosis, acne scars, keloids, tattoos, telangiectasia, squamous and basal cell carcinoma, warts and uneven pigmentation.
- · Treatment of cysts, abscesses, hemorrhoids and other soft tissue applications.
- · Blepharoplasty.
- · Site preparation for hair transplants.
- · The fractional scanner is for skin resurfacing.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The MATRIX LS-40 CO2 Surgical laser System incorporating a permanently articulated arm that delivers CO2 laser power in a wavelength of 10,600nm in its normal operations. The device is activated by means of a footswitch.
The Laser System is designed for use in an office or a clinic, which shall be a clean, dry and well-ventilated room with a door.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body soft tissues
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Office or a clinic
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 Matrix LS-40 CO2 Laser System has been conducted related non-clinical tests to identify the substantial equivalence from the predicate device. The tests include the concerning of electrical safety, EMC and the requirements of radiation safety, which contains the standards including IEC 60601-1:2005/COR1:2006/COR2:2007, IEC 60601-1-2:2007, IEC 60601-2-22:1995 and IEC 60825-1:2007.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name in a circular arrangement around an emblem. The emblem consists of a stylized representation of three human profiles facing right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 9, 2016
Shanghai Wonderful Opto-Electrics Tech. Co., Ltd. Mr. Jonathan Hu Medwheat (Shanghai) Medical Technology Co., Ltd. Yangpu District Liaoyuan East Road Shuangyang First Suite No. 33 Room 303 Shanghai, Shanghai China 200093
Re: K161356
Trade/Device Name: Matrix LS-40 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: July 25, 2016 Received: August 3, 2016
Dear Mr. Hu:
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. 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.
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
1
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Christopher J. Ronk -S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K161356
Device Name Powered Laser Surgical Instrument
Indications for Use (Describe)
It is indicated for incision, ablation, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology, neurosurgery, orthopaedics, general and thorasic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.
The CO2 System is intended for use in surgical applications requiring the ablation, vaporization, and coagulation of soft tissue in dermatology and plastic surgery, general surgery.
Dermatology, Plastic Surgery and General Surgery procedures:
- · Laser skin resurfacing.
- Treatment of furrows and wrinkles.
· Removal of skin tags, actinic keratosis, acne scars, keloids, tattoos, telangiectasia, squamous and basal cell carcinoma, warts and uneven pigmentation.
- · Treatment of cysts, abscesses, hemorrhoids and other soft tissue applications.
- · Blepharoplasty.
- · Site preparation for hair transplants.
- · The fractional scanner is for skin resurfacing.
| 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/1 description: The image shows the logo for SWOT. The logo is blue and features the word "SWOT" in a stylized font. There are two lines above and below the word "SWOT". The logo also includes the registered trademark symbol.
002_510(k) Summary
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Image /page/4/Picture/1 description: The image shows the logo for SWOT. The logo is blue and white, and it features the word "SWOT" in a stylized font. The letters are connected by a horizontal line. There is a registered trademark symbol in the upper right corner of the logo.
Date Prepared:September 9, 2016
510(k) Summary
[As required by 21 CFR 807.92]
1. Submitter's Information
| Name of Sponsor: | Shanghai Wonderful Opto-Electrics Tech. Co., Ltd. |
|---|---|
| Address: | 2F, Building 3, Lane 561, Nujiang Road (North),Shanghai |
| 200333, China | |
| Contact Name: | Amy Lee |
| Telephone No.: | 0086-021-62642623 |
| Fax No.: | 0086-021-52827988 |
| Email Address: | regulatory@wonderful-sh.com |
2. Correspondent's Information
| CompanyName: | Med-wheat Shanghai |
|---|---|
| Correspondent Name: | Jonathan Hu |
| Telephone No.: | 0086-021-65181421 |
| Email Address: | Jonathan.hu@medwheat.com |
3. Trade Name, Common Name, Classification
| Trade Name: | Matrix LS-40 CO2 Laser System |
|---|---|
| Common Name: | Medical Laser System |
| Mode Name: | Matrix LS-40 |
| Regulation Classification | Powered Laser Surgical Instrument |
| Product Code: | GEX |
| Classification Panel: | General and Plastic Surgery |
| Device Class: | II |
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Image /page/5/Picture/1 description: The image shows the logo for SWOT. The logo is blue and features the word "SWOT" in a stylized font. There are two lines above and below the word "SWOT". To the left of the word is a design that looks like two letter "S"s stacked on top of each other with a line going through them. There is a registered trademark symbol in the upper right corner of the image.
4. Identification of Predicate Device(s)
The identified predicatedevice within this submission is as follows:
TheCortex Laser System of Cynosure, Inc. dbaEllmanhas been cleared by FDA through 510(k) No.K150587 (Decision Date - July 21, 2015).
5. Description of the Device
The MATRIX LS-40 CO2 Surgical laser System incorporating a permanently articulated arm that delivers CO2 laser power in a wavelength of 10,600nm in its normal operations. The device is activated by means of a footswitch.
The Laser System is designed for use in an office or a clinic, which shall be a clean, dry and well-ventilated room with a door.
6. Indication for Use
It is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology, neurosurgery, orthopaedics, general and thorasic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.
The CO2 System is intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery, general surgery.
Dermatology, Plastic Surgery and General Surgery procedures:
- Laser skin resurfacing.
- Treatment of furrows and wrinkles.
•Removal of skin taqs, actinic keratosis, acne scars, keloids, tattoos, telangiectasia, squamous and basal cell carcinoma, warts and uneven pigmentation.
- Treatment of cysts, abscesses, hemorrhoids and other soft tissue applications.
- · Blepharoplasty.
- · Site preparation for hair transplants.
- The fractional scanner is for skin resurfacing.
510(k) Summary
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7. Technological Characteristics
The subject device in this 510(k) uses the same technology that is utilized in the predicate device. A comparison of technological characteristics is provided in the following table:
| Items | Matrix LS-40
CO2Laser System | Cortex Laser System
in K150587 | |
|----------------------------|----------------------------------------------------------------|----------------------------------------------------------------|----------|
| Technology Characteristics | | | |
| Laser Type | Sealed CO2 Laser Tube | Sealed CO2 Laser Tube | |
| Wavelength | 10.6 micron (10,600nm) | 10.6 micron (10,600nm) | |
| Laser Operation
Mode | Continuous Wave (CW), Blend
(PW), Super Pulse (SP) | Continuous Wave, Blend (PW),
Super Pulse | |
| Power to
Tissue | CW | 0.5-40W | 0.5-40W |
| | PW | 0.5-30W | 0.5-30W |
| | SP | 0.5-15W | 0.5-15W |
| Frequency
Range | CW | N/A | N/A |
| | PW | 30Hz | 30Hz |
| | SP | 20-240Hz | 20-240Hz |
| Peak Power | 200W | 200W | |
| Repetition Rate | 1-8 Hz/240 Hz Super Pulse | 1-8 Hz/240 Hz Super Pulse | |
| SuperPulse Duration | 10-1000ms | 10-1000ms | |
| Aiming Beam | 3mW (650nm diode) adjustable | 3mW (650nm diode) adjustable | |
| Spot Size | 100µm for surgical handpiece
150µm for fractional handpiece | 100µm for surgical handpiece
150µm for fractional handpiece | |
| Articulated Arm | 7-joint articulated arm | 7-joint articulated arm | |
| Cooling Type | Closed Loop Liquid | Closed Loop Liquid | |
| User Interface | LCD Touch Screen | LCD Touch Screen | |
| Dimension | 34cm46cm96cm | 150cm46cm 31cm | |
| Weight | 46.5Kg | 60kg | |
| Power Input | 110 - 120 VAC, 10 A, 50-60 Hz | 110 - 120 VAC, 10 A, 50-60 Hz | |
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Image /page/7/Picture/1 description: The image is a logo for SWOT. The logo is blue and white. The word "SWOT" is written in blue letters, with a blue line underneath. There is a blue oval shape to the left of the word "SWOT" with the letters "S" written twice inside the oval. There is a registered trademark symbol in the upper right corner of the logo.
8. Discussion of Non-clinical Testing
The Matrix LS-40 CO2 Laser System has been conducted related non-clinical tests to identify the substantial equivalence from the predicate device. The tests include the concerning of electrical safety, EMC and the requirements of radiation safety, which contains the standards including IEC 60601-1:2005/COR1:2006/COR2:2007, IEC 60601-1-2:2007, IEC 60601-2-22:1995 and IEC 60825-1:2007.
9. Conclusions
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, it is concluded, basing on performance testing, indication for use, and technology, the subject device is substantially equivalent to the predicate device K150587.