(137 days)
Not Found
No
The summary describes a standard CO2 laser system with manual control via a touchscreen interface and does not mention any AI or ML capabilities.
Yes
The device is described as performing human tissue vaporization and coagulation for various medical specialties, which are therapeutic procedures. It is also explicitly mentioned in the performance studies that it complies with "Particular Requirements For Basic Safety And Essential Performance Of Surgical, Cosmetic, Therapeutic And Diagnostic Laser Equipment."
No
The device is described as a CO2 Laser Machine used for vaporization and coagulation of human tissue in various surgical and therapeutic applications, not for diagnosing conditions.
No
The device description explicitly details hardware components like a laser, control panel, LCD touch-screen, and micro-controller, indicating it is a physical medical device with integrated software, not a software-only device.
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 "human tissue vaporization, coagulation" in various surgical and medical procedures. This involves direct interaction with the patient's body for treatment purposes.
- Device Description: The description reinforces this by explaining how the laser vaporizes and heats tissue during treatment.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic information. This CO2 Laser Machine is a therapeutic device used for surgical procedures on the patient's body.
N/A
Intended Use / Indications for Use
The CO2 Laser Machine is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The CO2 Laser Machine is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.
The CO2 laser machine has two modes, continuous mode and multi-pulse mode. It utilizes CO2 laser to vaporize and heat tissue.
During the treatment, the water in skin tissues absorbs laser energy and then vaporizes.
Laser parameters and other system features are controlled from the control panel on the console, which provides an interface to the system's micro-controller through a LCD touch-screen.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human tissue (in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital
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)
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- IEC 60601-1:2012 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance;
- IEC 60601-2-22:2007, Medical Electrical Equipment - Part 2-22: Particular Requirements For Basic Safety And Essential Performance Of Surgical, Cosmetic, Therapeutic And Diagnostic Laser Equipment;
- IEC 60825-1:2014, Safety of laser products - Part 1: Equipment classification and requirements.
- IEC 60601-1-2:2014, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility-Requirements and tests.
- ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro cytotoxicity
- ISO 10993-10:2010, Biological Evaluation of Medical Device, Part 10-Test for irritation and delay-type hypersensitivity
- Software Validation & Verification Test
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 22, 2021
Zhengzhou Bestview St Co., Ltd. % Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd Rm. 912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing, Beijing 102401 China
Re: K211735
Trade/Device Name: CO2 Laser Machine, Model: BW-203B 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: September 18, 2021 Received: September 21, 2021
Dear Ray Wang:
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
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-reporting-
combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-
mdr-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.
Purva Pandya 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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name CO2 Laser Machine Model: BW-203B
Indications for Use (Describe)
The CO2 Laser Machine is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
3
K211735 510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
-
- Date of Preparation
09/17/2021
- Date of Preparation
-
- Applicant Name and Address
Zhengzhou Bestview St Co., Ltd.
Room 2004, 20F, Lande Center, Huayuan Road, Jinshui District, 450000 Zhengzhou, Henan Province, China
-
- Contact Person Information YangChun Jia General Manager Tel: +86-15803801506 Email: info@bestviewmedical.com
-
- Submission Correspondent
Mr. Ray Wang Beijing Believe Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing City, China, 102401 Tel: +86-18910677558 Fax: +86-10-56335780 Email: ray.wang@believe-med.com
4
-
- Identification of Proposed Device Trade Name: CO2 Laser Machine Common Name: Powered Laser Surgical Instrument Model: BW-203B Classification Name: Powered Laser Surgical Instrument Classification: II; Product Code: GEX; Regulation Number: 21 CFR 878.4810; Review Panel: General& Plastic Surgery;
- Identification of Primary Predicate 6. 510(k) Number: K200042 Product Name: CO2 Laser System Manufacturer: Beijing Superlaser Technology Co., Ltd.
Device Description 7.
The CO2 Laser Machine is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.
The CO2 laser machine has two modes, continuous mode and multi-pulse mode. It utilizes CO2 laser to vaporize and heat tissue.
During the treatment, the water in skin tissues absorbs laser energy and then vaporizes.
Laser parameters and other system features are controlled from the control panel on the console, which provides an interface to the system's micro-controller through a LCD touch-screen.
-
Indication For Use 8.
The CO2 Laser Machine is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology. -
Substantially Equivalent (SE) Comparison 9.
Table 3 General Comparison
| ITEM | Proposed Device | Predicate Device (K200042) | Remark |
|---|---|---|---|
| Product Code | GEX | GEX | SAME |
| Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 | SAME |
5
| Class | 2 | 2 | SAME |
|---|---|---|---|
| Where used | Hospital | Hospital | SAME |
| Intended Use | The CO2 Laser Machine is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology. | The CO2 Laser System is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology. | SAME |
Table 4 Performance Comparison
| ITEM | Proposed Device K211735 | Predicate Device (K200042) | Remark |
|---|---|---|---|
| Maximum Power | 30W | 30W | SAME |
| work mode | Continuous, Muti-Pulse | Single Pulse, Continuous, Muti-Pulse | SAME |
| Wavelength | 10.6 um | 10.6 um | SAME |
| Mode Structure | TEM00 | TEM00 | SAME |
| Beam delivery | 7 knucklearmkey joints light arm | 7 knucklearmkey joints light arm | SAME |
| Light arm | 1.36m | 1.36m | SAME |
| Handpiece Type | Be part of light arm | Be part of light arm | SAME |
| Aiming Beam | 630-650nm red diode laser (≤5 mW) | 650nm red diode laser(≤ 5 mW) | SAME |
| Spot size | 0.5 mm | 0.5mm | SAME |
| Output Power | 1-30W | 1-30W | SAME |
| Pulse Durtion | 1-1000 ms | 1-1000 ms | SAME |
| Control System | Touch screen, footswitch | Touch screen, footswitch | SAME |
| Laser operation | Footswitch | Footswitch | SAME |
| Laser medium/energy source | CO2 | CO2 | SAME |
| Cooling System | Water + Air cooling | Air cooling | SIMILAR |
| Clean Method | 70% isopropanol | 70% isopropyl alcohol | SAME |
| Dimension | 61 cm x 32 cm x 22 cm | 37.5 cm x 29 cm x 113 cm | Analysis |
| Weight | 35 kg | 40 kg | Analysis |
| Power input | AC100V/60Hz | 110V 60Hz or 230V 50Hz | SAME |
Table 5 Safety Comparison
| Item | Proposed Device | Predicate Device (K200042) | Remark |
|---|---|---|---|
| EMC, Electrical and Laser Safety | |||
| Electrical Safety | Comply with IEC 60601-1, IEC | ||
| 60601-2-22 | Comply with IEC 60601-1, IEC | ||
| 60601-2-22 | SAME | ||
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | SAME |
| Laser Safety | Comply with IEC 60601-2-22, IEC 60825 | Comply with IEC 60601-2-22, IEC 60825 | SAME |
| Patient Contact Materials and Biocompatibility |
6
510(k) Summary
| Patient Contact
| Materials | handpiece | handpiece | SAME |
|---|---|---|---|
| Cytotoxicity | No Cytotoxicity | Comply with ISO 10993-10 and | |
| ISO 10993-5 | SAME | ||
| Sensitization | No evidence of sensitization | ||
| Irritation | No evidence of irritation |
Analysis
The difference between proposed device and predicate device lies in the appearance (dimension, weight). The difference will not affect the safety and effectiveness of proposed device in comparison to the predicate.
10. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
-
IEC 60601-1:2012 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance;
-
IEC 60601-2-22:2007, Medical Electrical Equipment - Part 2-22: Particular Requirements For Basic Safety And Essential Performance Of Surgical, Cosmetic, Therapeutic And Diagnostic Laser Equipment;
-
IEC 60825-1:2014, Safety of laser products - Part 1: Equipment classification and requirements.
-
IEC 60601-1-2:2014, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility-Requirements and tests.
-
ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro cytotoxicity
-
ISO 10993-10:2010, Biological Evaluation of Medical Device, Part 10-Test for irritation and delay-type hypersensitivity
-
Software Validation & Verification Test
-
- Clinical Testing
No clinical study is included in this submission.
12. Conclusion
Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device.