(97 days)
No
The summary describes a standard CO2 laser system for tissue vaporization and resurfacing, with no mention of AI or ML in its operation, intended use, or performance studies.
Yes
The device is described as being used for human tissue vaporization in dermatology, plastic surgery, and general surgery for treatment of wrinkles and skin resurfacing, which are therapeutic applications.
No
Explanation: The device description states its purpose is for tissue vaporization and coagulation, including treatment for wrinkles and skin resurfacing. It does not mention any function related to diagnosing medical conditions.
No
The device description clearly states it consists of a console, articulated arm, and foot switch, which are hardware components. It also describes a laser system that physically interacts with tissue.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body (in vitro).
- Device Function: The description clearly states the device is a CO2 Laser System used for "human tissue vaporization and coagulation as well as for the treatment of wrinkles and skin resurfacing." This is a therapeutic device that directly interacts with and modifies human tissue on the body.
- Lack of IVD Characteristics: The description does not mention any analysis of samples, diagnostic testing, or providing information about a person's health based on laboratory analysis.
Therefore, the CO2 Laser System (Model: GP900F) is a therapeutic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The equipment is used for human tissue vaporization in dermatology, plastic surgery, and general surgery. The classical scanner is only for the treatment of wrinkles and skin resurfacing.
Product codes
GEX
Device Description
The subject device, CO2 Laser System (Model: GP900F) 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 absorbs laser energy and evaporates. By setting up the suitable energy and other parameters on skin tissue, the device can be used for human tissue vaporization and coagulation as well as for the treatment of wrinkles and skin resurfacing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
Non-clinical testing is conducted to verify that the CO2 Laser System meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate device. The testing results demonstrate that the Proposed device complies with the following standards:
- A IEC60601-1, Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance
- A IEC 60601-2-22, Medical electrical equipment-Part2: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
- IEC 60825-1. Safety of Laser Products- Part 1: Equipment classification and requirements
- IEC60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
The biocompatibility evaluation for the CO2 Laser 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 In Vitro Cytotoxicity, Skin Sensitization and Intracutaneous Reactivity was conducted in compliance with:
- A ISO 10993-5, Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
- A ISO 10993-10, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
Software verification and validation test according to the requirements of the FDA A "Guidance for Pre Market Submissions and for Software Contained in Medical Devices". The software for this device was considered as a "moderate" level of concern. Software validation demonstrated that the software functions as specified in the software requirement specifications.
Bench performance testing to show that the device delivers set laser energy A parameters within specifications.
Key Metrics
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.
0
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: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
September 12, 2019
Feiying Drug & Medical Consulting Technical Service Group Becky Chen Registered Engineer B-3F 3005, Bldg. 1, Southward Ruifeng Business Center, No. 22 Guimiao Rd. Shenzhen, CN 518000 Guangdong
Re: K191518
Trade/Device Name: CO2 Laser System (Model: GP900F) 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 15, 2019 Received: August 19, 2019
Dear Becky Chen:
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 medical devices and radiation-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.
Purva Pandya 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) K191518
Device Name CO2 Laser System (Model: GP900F)
Indications for Use (Describe)
The equipment is used for human tissue vaporization in dermatology, plastic surgery, and general surgery. The classical 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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3
510 (k) Summary
This "510(k) Summary" of 510(k) safety and effectiveness information is submitted in accordance with requirements of Title 21, CFR Section 807.92.
(1) Applicant information:
| 510(k) owner's name: | SHENZHEN GSD TECH CO., LTD |
|---|---|
| Address: | BUILDING A JUNSD HI-TECH PARK, WEST OF |
| BAO'AN RD. WATCH & CLOCK BASE, GUANGMING | |
| DISTRICT, SHENZHEN, GUANGDONG, CHINA | |
| Contact person: | Jiancheng zhang |
| Phone number: | +86-13632740353 |
| Fax number: | +86-0755-29109786 |
| Email: | 535140627@qq.com |
| Date of summary prepared: | 2019-09-11 |
(2) Proprietary name of the device
| Trade name/model: | CO2 Laser System (Model: GP900F) |
|---|---|
| Common name: | Laser Surgical Instrument for Use In General And Plastic |
| Surgery And In Dermatology | |
| Regulation number: | 21CFR 878.4810 |
| Product code: | GEX |
| Review panel: | General & Plastic Surgery |
| Regulation class: | II |
(3) Predicate devices
| Primary Predicate | Reference Predicate | |
|---|---|---|
| Sponsor | Beijing Sincoheren Science and | |
| Technology Development Co., Ltd. | Jeisys Medical Inc. | |
| Device | ||
| Name | CO2 Laser Therapy System | EdgeOne CO2 Laser |
| 510(k) | ||
| Number | K162398 | K162169 |
| Product | ||
| Code | GEX | GEX, ONG |
| Regulation | ||
| Number | 21 CFR 878.4810 | 21 CFR 878.4810 |
| Regulation | II | II |
4
Class
(4) Description/ Design of device:
The subject device, CO2 Laser System (Model: GP900F) 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 absorbs laser energy and evaporates. By setting up the suitable energy and other parameters on skin tissue, the device can be used for human tissue vaporization and coagulation as well as for the treatment of wrinkles and skin resurfacing.
(5) Intended use / Indications for use:
The equipment is used for human tissue vaporization, coagulation in dermatology, plastic surgery, and general surgery. The classical scanner is only for the treatment of wrinkles and skin resurfacing.
(6) Materials
| Component name | Material of
Component | Body Contact
Category | Contact Duration |
|-------------------------|--------------------------|--------------------------|--------------------|
| Treatment hand
piece | Stainless steel 316L | Surface skin contact | Less than 24 hours |
The treatment hand piece used in the CO2 Laser Systems has passed the Biocompatibility test. For details, please refer to "Biocompatibility Discussion".
(7) Technological characteristics and substantial equivalence:
| Item | Proposed device | Primary Predicate | Reference
Predicate | Remark |
|----------------------|-------------------------------------|-----------------------------------------------------------------------------|------------------------|--------|
| Trade name | CO2 Laser System
(Model: GP900F) | CO2 Laser Therapy
System | EdgeOne CO2
Laser | / |
| Manufacturer | SHENZHEN GSD
CO., LTD | Beijing Sincoheren
Science and
Technology
Development Co.,
Ltd. | JEISYS
MEDICAL INC. | / |
| 510 (k)
number | / | K162398 | K162169 | / |
| Regulation
number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Same |
5
| Regulation
description | Laser surgical
instrument for use in
general and plastic
surgery and in
dermatology. | Laser surgical
instrument for use in
general and plastic
surgery and in
dermatology. | Laser surgical
instrument for use
in general and
plastic surgery and
in dermatology. | Same |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Product
code | GEX | GEX | GEX | Same |
| Class | II | II | II | Same |
| Indications
for use/
Intended
use | The equipment is
used for human
tissue vaporization,
coagulation in
dermatology, plastic
surgery, and general
surgery. The
classical scanner is
only for the
treatment of
wrinkles and skin
resurfacing. | 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. | 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(EN
T), gynaecology,
neurosurgery,
orthopaedics,
general and
thoracic surgery
(including open
and endoscopic),
dental and oral
surgery and
genitourinary
surgery. The use
with the scanning
unit is indicated for
ablative skin
resurfacing. | Same |
| Location for
use | Prescription Use | Prescription Use | Prescription Use | Same |
| Basic unit specifications | | | | |
| Power
supply | 110-240VAC,
50-60Hz | 110-240VAC,
50-60Hz | 230V~, 50/60Hz | Same |
| Dimensions | 480mm380mm10
53mm | 460mm×430mm×11
70mm | NA | Different
Note 1 |
| Weight | 46kg | 65kg | NA | Different |
| | | | | Note 1 |
| Major
components | Console, articulated
arm and a foot
switch. | Console, articulated
arm and a foot
switch. | Main console unit,
articulated arm and
a foot switch. | Same |
| Compliance
with
voluntary
standards | IEC 60601-1
IEC 60601-2-22
IEC 60825-1
IEC 60601-1-2 | IEC 60601-1
IEC 60825-1
IEC 60601-1-2 | IEC 60601-1
IEC 60601-2-22
IEC 60601-1-2 | Same |
| Performance specification | | | | |
| Output
Power
(Maximum) | 30W | 30W | 30W | Same |
| Work Mode | Classical mode,
Surgical mode
(Single Pulse,
Continuous,
Muti-Pulse) | Scan (Single Pulse,
Continuous,
Muti-Pulse) | Fractional mode,
normal mode (CW,
Pulse, Single Pulse,
Repeat, Group
pulse, Ultra) | Same |
| Laser
Medium/En
ergy Source | CO2 | CO2 | CO2 | Same |
| CO2 Laser
Wavelength | 10600nm | 10600nm | 10600nm | Same |
| Aiming
Beam
Wavelength | Red diode laser
650nm±10nm | Red diode laser 635
nm | Red diode laser
655 +/- 10nm | Similar
Note 2 |
| Aiming
Beam
Power | IEC 60825-1. Safety of Laser Products- Part 1: Equipment classification and requirements
-
IEC60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
The body-contacting components of this device are the treatment head. The biocompatibility evaluation for the CO2 Laser 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 treatment head is considered skin and subcutaneous tissue contacting for a duration of less than 24 hours. The biocompatible testing included In Vitro Cytotoxicity, Skin Sensitization and Intracutaneous Reactivity was conducted in compliance with:
- A ISO 10993-5, Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
- A ISO 10993-10, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
We have also conducted:
- Software verification and validation test according to the requirements of the FDA A "Guidance for Pre Market Submissions and for Software Contained in Medical Devices". The software for this device was considered as a "moderate" level of concern. Software validation demonstrated that the software functions as specified in the software requirement specifications.
- Bench performance testing to show that the device delivers set laser energy A parameters within specifications.
(9) Conclusion
Based on the above analysis and tests performed. it can be concluded that the subject device CO2 Laser System (Model: GP900F) is Substantially Equivalent (SE) to the predicate devices.