(168 days)
Not Found
No
The summary describes a standard CO2 laser device and its intended uses. There is no mention of AI, ML, image processing, or any data-driven decision-making components. The performance studies focus on electrical safety and laser performance standards, not AI/ML validation.
Yes.
The device's intended use is for human tissue vaporization and coagulation in various medical fields, and the predicate device is explicitly named a "CO2 Laser Therapy System," indicating its therapeutic purpose.
No
The device is described for tissue vaporization and coagulation, which are therapeutic actions, not diagnostic ones.
No
The device description explicitly states it is "CO2 Laser Equipment" and describes physical components and mechanisms of action related to a laser, indicating it is a hardware device with associated 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 in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology." This describes a therapeutic or surgical procedure performed directly on the patient's body.
- Device Description: The description reinforces this by explaining the device "emits laser energy at 10.6 um wavelength to induce human tissue vaporization, coagulation." This is a physical interaction with the tissue, not an analysis of a sample taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue samples) or providing diagnostic information based on such analysis. IVDs are designed to examine specimens in vitro (outside the body) to provide information about a person's health.
This device is a surgical/therapeutic laser, not a diagnostic tool that analyzes samples.
N/A
Intended Use / Indications for Use
The CO2 Laser Equipment is used for human tissue vaporization in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.
Product codes
GEX
Device Description
The subject device CO2 Laser Equipment is a carbon dioxide laser used in medical and aesthetic industry. The device emits laser energy at 10.6 um wavelength to induce human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.
The CO2 Laser Equipment includes two models US800N, the two models have same mechanism of action, structure, material, motherboard, software, principle and specification. The difference is appearance and size. The detailed difference shown as following:
Table 1 The Difference of Models
| Item | US800 | US800N |
|---|---|---|
| Size | 480mm540mm1240mm | 440mm540mm1020mm |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 subject device met all design specifications and was Substantially Equivalent (SE) to the predicate device. The following tests were conducted:
- A AAMI ES60601-1:2005+A1:2012 Medical Electrical Equipment - Part 1: General Requirements for Safety And Essential Performance;
-
IEC 60601-2-22:2007+A1:2012, 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.
-
Software Validation & Verification Test
-
Bench Testing to verify the performance
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.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 1, 2022
Beijing Globalipl Development 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: K212611
Trade/Device Name: CO2 Laser Equipment 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: January 4, 2022 Received: January 10, 2022
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 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.
Purva Pandya 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) K212611
Device Name CO2 Laser Equipment
Indications for Use (Describe)
The CO2 Laser Equipment is used for human tissue vaporization in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.
| 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 is submitted in accordance with the requirements of 21 CFR Section 807.92.
The assigned 510(k) Number: K212611
-
Date of Preparation 1.
1/31/2022 -
- Applicant Name and Address
Beijing Globalipl Development Co., Ltd.
No. 31, Sanguanmiao Alley, Zhuolu Town, Zhuolu County, Zhangjiakou City, Hebei, China, 072750
-
Contact Person Information 3. Liu Jun
QA Manager Tel: +86-15169727366 Fax: +86-10-60212336 Email: register@globalipl.com -
- Submission Correspondent
Mr. Ray Wang
- Submission Correspondent
Beijing Believe-Med 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 Equipment Common Name: Powered Laser Surgical Instrument Model(s): US800/US800N 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: K192528 Product Name: CO2 Laser Therapy System Manufacturer: Shangdong Huamei Technology Co., Ltd.
7. Device Description
The subject device CO2 Laser Equipment is a carbon dioxide laser used in medical and aesthetic industry. The device emits laser energy at 10.6 um wavelength to induce human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.
The CO2 Laser Equipment includes two models US800N, the two models have same mechanism of action, structure, material, motherboard, software, principle and specification. The difference is appearance and size. The detailed difference shown as following:
Table 1 The Difference of Models
| Item | US800 | US800N |
|---|---|---|
| Size | 480mm540mm1240mm | 440mm540mm1020mm |
- Indication For Use 8.
The CO2 Laser Equipment is used for human tissue vaporization in dermatology and
5
plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.
-
- Substantially Equivalent (SE) Comparison
Table 2 General Comparison
| ITEM | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| Product Code | GEX | GEX | SAME |
| Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 | SAME |
| Class | 2 | 2 | SAME |
| Where used | hospital | hospital | SAME |
| Intended Use | The CO2 Laser Equipment is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology. | The CO2 Laser Therapy Machine is used for human tissue vaporization, coagulation in dermatoloty and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology. | SAME |
Table 3 Performance Comparison
| ITEM | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| Maximum Power | 30W | 30W | SAME |
| Work mode | Single Pulse Mode, Continuous Pulse | ||
| Mode, Multi Pulse Mode | Surgery (Single Pulse, Continuous, | ||
| Muti-Pulse) | SAME | ||
| Wavelength | 10.6 um | 10.6 um | SAME |
| Beam delivery | 7 joint Light guide arm | 7 knucklearmkey joints light arm | SAME |
| Light arm | 1.36m | 1.36m | SAME |
| Aiming Beam | 650nm/0.5mW | 630-650nm red diode laser (≤5 mW) | SAME |
| Spot size | 0.5 mm | 0.5 mm | SAME |
| Pulse Setting | Single Pulse / | ||
| 0.1ms-1000ms. | |||
| Multi Pulse | |||
| Continuous | |||
| 1-30W | Single Pulse / | ||
| 0.1ms-1000ms. | |||
| Multi Pulse | |||
| Continuous | |||
| 1-30W | SAME | ||
| Power calibration | Period of 1 year | Period of 1 year | SAME |
| Control System | Touch screen, footswitch | Touch screen, footswitch | SAME |
| Laser operation | Footswitch | Footswitch | SAME |
| Laser medium/ energy source | CO2 | CO2 | SAME |
| Cooling System | Air cooling | Air cooling | SAME |
| Clean Method | 70% medical alcohol | 70% medical alcohol | SAME |
| Patient Contacted Part | Skin | Skin | SAME |
| Dimension | US800:48x54x124cm | ||
| US800N:44x54x102cm | 6642125cm (without light arm) | Analysis | |
| Weight | 65Kg | 80 kg | Analysis |
| Power input | AC 110V, 50/60Hz | AC 110V/60Hz | SAME |
6
Analysis
The proposed device is different in dimensions and weight from the predicate device. By complying with IEC 60601-1, the mechanical performance of the subject device is determined to be acceptable. Therefore, this difference is not likely to adversely affect the safety and effectiveness of the subject device in comparison to the predicate device.
| Item | Proposed Device | Predicate Device | 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 | SE | ||
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | SE |
| Laser Safety | Comply with IEC 60601-2-22, IEC 60825 | Comply with IEC 60601-2-22, IEC 60825 | SE |
| Patient Contact Materials and Biocompatibility | |||
| Patient Contact | |||
| Materials | No patient contacting | ||
| components/materials claimed | / | Analysis |
Table 4 Safety Comparison
10. Non-Clinical Testing
Non clinical tests were conducted to verify that the subject device met all design specifications and was Substantially Equivalent (SE) to the predicate device. The following tests were conducted:
- A AAMI ES60601-1:2005+A1:2012 Medical Electrical Equipment - Part 1: General Requirements for Safety And Essential Performance;
-
IEC 60601-2-22:2007+A1:2012, 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.
-
Software Validation & Verification Test
-
Bench Testing to verify the performance
-
- Clinical Testing
No clinical study is needed or included in this submission.
-
- Conclusion
7
The conclusion drawn from the nonclinical tests demonstrates that the subject device CO2 Laser Equipment (US800/US800N) is substantially equivalent to the legally marketed predicate device K192528.