(314 days)
No reference devices were used in this submission.
No
The description focuses on the physical principles of laser therapy and standard software validation, with no mention of AI or ML algorithms for image processing, parameter optimization, or other functions.
Yes
The device is described as a "CO2 Diode Laser Therapy System" and its intended use includes "treatment of wrinkles and skin resurfacing," as well as "human tissue vaporization, coagulation in dermatology, plastic surgery, and general surgery," which are therapeutic applications.
No
This device is used for tissue vaporization and coagulation, aimed at therapeutic treatments like wrinkle removal and skin resurfacing, rather than diagnosing conditions.
No
The device description explicitly states it consists of a console, articulated arm, and foot switch, which are hardware components. The software is part of a larger hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for human tissue vaporization and coagulation in various surgical procedures, and for treating wrinkles and skin resurfacing. This involves direct interaction with the patient's body for therapeutic purposes.
- Device Description: The device is a CO2 laser system that uses light energy to interact with tissue. This is a therapeutic device, not a diagnostic one.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening. This device does not perform such tests on samples.
The device described is a therapeutic medical device that uses laser energy to treat tissue.
N/A
Intended Use / Indications for Use
The equipment is used for human tissue vaporization in dermatology, plastic surgery, and general surgery. The fractional scanner is only for the treatment of wrinkles and skin resurfacing.
Product codes
ONG, GEX
Device Description
The CO2 Diode Laser Therapy Systems mainly consist of console, articulated arm and a foot switch. CO2 laser wavelength is 10600nm, which is used to gasify the skin tissue based on the principle of the theory selective photothermolysis. The water in skin is the main target of the CO2 fractional laser, after absorbed the energy of the laser, the water will release heat, then be evaporated and gasified immediately, the cutaneous lesion will be eliminated instantly. By setting up the suitable energy and other parameters on skin tissue based on its specific thermal relaxation time, the healthy tissue can be prevented from being harmed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human tissue (specifically skin)
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
Biocompatibility testing: The biocompatibility evaluation for the CO2 Laser Therapy Systems was conducted in accordance with the guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" as recognized by FDA. The biocompatible testing included the following tests: Cytotoxicity, Sensitization, Irritation. The treatment head is considered skin and subcutaneous tissue contacting for a duration of less than 24 hours.
Electrical safety and electromagnetic compatibility (EMC): Electrical safety and EMC testing were conducted on the CO2 Laser Therapy Systems. The device complies with the IEC 60601-1, standard for safety and the IEC 60601-1-2 standard for EMC.
Performance testing: Performance testing was conducted on the device according to IEC 60825-1.
Software Verification and Validation Testing: Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a failure or latent flaw could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider.
Animal Study: The subject of this premarket submission, CO2 Laser Therapy Systems, does not require clinical studies to support substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with a flowing design element below them, possibly representing water or movement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 6, 2017
Beijing Sincoheren Science and Technology Development Co. % Mr. Mike Gu Guangzhou Osmunda Medical Device Technical Service Co., Ltd 7th Floor, Jingui Business Building, No.982 Congyun Rd Baiyun District Guangzhou, 510420 China
Re: K162398
Trade/Device Name: Co2 Laser Therapy Systems 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: ONG, GEX Dated: June 16, 2017 Received: June 19, 2017
Dear Mr. Gu:
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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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 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/ResourcesforYou/Industry/default.htm. 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
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, Jennifer R. Stevenson -
S3
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
2
Indications for Use
510(k) Number (if known) K162398
Device Name CO2 Laser Therapy Systems
Indications for Use (Describe)
The equipment is used for human tissue vaporization in dermatology, plastic surgery, and general surgery. The fractional scanner is only for the treatment of wrinkles and 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/0 description: The image is a green square with a white design on it. The white design appears to be a stylized letter or symbol, possibly a combination of curved and straight lines. The design is abstract and does not resemble any common object or shape. The overall impression is a simple, modern logo or icon.
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
SUBMITTER l.
Beijing Sincoheren Science and Technology Development Co., Ltd. Room 305, No.43, Xizhimen North Street, Haidian District, Beijing, 100044, China Phone: +86-(0)10-57734966
Fax: +86-(0)10-82290038
| Primary Contact Person: | Mike Gu |
|---|---|
| Regulatory Affairs Manager | |
| OSMUNDA Medical Device Consulting Co., Ltd | |
| Tel: (+86) 20-6232 1333 | |
| Fax: (+86) 20-8633 0253 | |
| Secondary Contact Person: | Xin Wang |
| Quality Manager | |
| Beijing Sincoheren Science and Technology Development | |
| Co., Ltd. | |
| Tel: (+86) 10-82294249-8002 | |
| Fax: (+86) 10-82294249-8007 | |
| Date prepared: | Aug 20, 2016 |
II. DEVICE
| Name of Device: | CO2 Laser Therapy Systems |
|---|---|
| Common/Usual Name: | CO2 Laser Therapy Systems |
| Classification Names: | Powered Laser Surgical Instrument (21 CFR 878.4810) |
| Regulation Class: | II |
| Product Code: | GEX |
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Image /page/4/Picture/1 description: The image is a green square with a white design on it. The white design appears to be a stylized letter or symbol, possibly a combination of curved and straight lines. The design is not easily recognizable as a standard letter or symbol. The overall impression is a simple, abstract logo or icon.
III. PREDICATE DEVICE
CO2 Laser Therapy Machine, K161925
This predicate has not been subject to a design-related recall. No reference devices were used in this submission.
DEVICE DESCRIPTION IV.
The CO2 Diode Laser Therapy Systems mainly consist of console, articulated arm and a foot switch. CO2 laser wavelength is 10600nm, which is used to gasify the skin tissue based on the principle of the theory selective photothermolysis. The water in skin is the main target of the CO2 fractional laser, after absorbed the energy of the laser, the water will release heat, then be evaporated and gasified immediately, the cutaneous lesion will be eliminated instantly. By setting up the suitable energy and other parameters on skin tissue based on its specific thermal relaxation time, the healthy tissue can be prevented from being harmed.
V. INDICATIONS FOR USE
The equipment is used for human tissue vaporization, coagulation in dermatology, plastic surgery, and general surgery. The fractional scanner is only for the treatment of wrinkles and skin resurfacing.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
| Specification | Proposed device | Predicate device | Discussion of Differences |
|---|---|---|---|
| K number | K162398 | K161925 | N/A |
| Manufacturer | Beijing Sincoheren Science | ||
| and Technology | |||
| Development Co., Ltd. | Beijing ADSS Development | ||
| Co., Ltd | N/A | ||
| Device name | CO2 Laser Therapy System | CO2 Laser Therapy Machine | N/A |
| Intended use | The equipment is used for | ||
| human tissue vaporization, | |||
| coagulation in | |||
| dermatology, plastic | |||
| surgery, and general | |||
| surgery. The fractional | |||
| scanner is only for the | |||
| treatment of wrinkles and | |||
| skin resurfacing. | The equipment is used for | ||
| human tissue vaporization, | |||
| coagulation in dermatology | |||
| and plastic surgery, general | |||
| surgery, gynecology, | |||
| podiatry, dental and | |||
| otorhinolaryngology. | Smaller intended use. | ||
| The difference does not | |||
| raise different questions of | |||
| safety and effectiveness. | |||
| Specification | Proposed device | Predicate device | Discussion of Differences |
| Output power | |||
| (Maximum) | 30W | 30W | Identical |
| Work mode | Scan (Single Pulse, | ||
| Continuous, Muti-Pulse) | Surgery (Single Pulse, | ||
| Continuous, Muti-Pulse) | Identical | ||
| Laser medium/energy | |||
| source | CO2 | CO2 | Identical |
| CO2 laser wavelength | 10600nm | 10600nm | Identical |
| Aiming Beam | |||
| wavelength | Red diode laser | ||
| 635 nm | Red diode laser | ||
| 650 nm | Similar aiming beam | ||
| wavelength. | |||
| The difference does not | |||
| raise different questions of | |||
| safety and effectiveness. | |||
| Aiming Beam power |