(111 days)
Not Found
No.
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description outlines a physical process (laser heating water) without any indication of intelligent processing or decision-making.
Yes
The device is described as being used for "body soft tissue vaporization and coagulation in dermatology and plastic surgery, general surgery, gynecology," which are therapeutic applications. It also mentions inducing hemostasis, fibroblast stimulation, and neocollagenesis, all of which are therapeutic effects.
No
Explanation: The CO2 Laser Machine is described as being used for "body soft tissue vaporization and coagulation" and inducing "hemostasis" and "neocollagenesis." These are therapeutic or surgical actions, not diagnostic ones. Diagnostic devices are used to identify or examine a condition.
No
The device description clearly indicates it is a physical CO2 laser machine that generates a 10,600nm wavelength to interact with tissue, requiring extensive hardware-related performance and safety testing (e.g., ISO 10993 for biological evaluation, IEC 60601 series for electrical safety, IEC 60825-1 for laser safety). These are characteristic tests for physical medical devices, not software-only devices.
No.
The device is a CO2 laser machine used for surgical procedures like vaporization and coagulation of soft tissue. It is not designed to perform tests on specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
N/A
Intended Use / Indications for Use
The CO2 Laser Machine (Lume) is used for body soft tissue vaporization and coagulation in dermatology and plastic surgery, general surgery, gynecology.
Product codes
GEX
Device Description
The CO2 Laser Machine generate a 10,600nm wavelength, which is absorbed by water in the tissue.
The laser energy heats up the water until it reaches a boiling point causing the evaporation of the affected tissue. Some heat is absorbed by tissue adjacent to the ablated target area, causing tissue coagulation which induces hemostasis (the cessation of bleeding) as well as thermal stimulation of deep skin layers, which induces fibroblast stimulation and neocollagenesis (the formation of new collagen).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body soft tissue
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)
Summary of Non-clinical Performance Tests:
- ANSI AAMI ES60601-1: 2005&A1:2012 &A2:2021: Medical Electrical Equipment - Part 1: General Requirement for Basic Safety and Essential Performance;
- IEC 60601-1-2: 2014+A1:2020, Medical Electrical Equipment - Part 1-2: General Requirement for Basic Safety and Essential Performance- Collateral Standard: Electromagnetic Disturbances- Requirements and Tests;
- IEC 60601-2-22:2019, 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
Biocompatibility tests:
- ISO 10993-5: 2009 Biological Evaluation of Medical Devices - Part 5: Tests for in vitro cytotoxicity.
- ISO 10993-10 2021, Biological Evaluation of Medical Devices - Part 10: Tests for Skin sensitization.
- 10993-23: 2021, Biological Evaluation of Medical Devices - Part 23: Tests for irritation.
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.
FDA 510(k) Clearance Letter - CO2 Laser Machine (Lume)
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID# 04017.07.05
Silver Spring, MD 20993
www.fda.gov
June 9, 2025
Nanjing Bestview Laser S&T Co., Ltd.
Jing Wang
Management Representative
1st & 2nd Fl, Bldg 5, Area 1, Phase 2 Liandong U Valley
Science & Technology Innovation Pk,No.1 Hengyi Rd,Nanjing Ec
Nanjing, Jiangsu 210000
China
Re: K250465
Trade/Device Name: CO2 Laser Machine (Lume)
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: May 13, 2025
Received: May 13, 2025
Dear Jing 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 (the 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 available 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.
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K250465 - Jing Wang Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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K250465 - Jing Wang Page 3
assistance/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,
TANISHA L. HITHE -S
Digitally signed by TANISHA L. HITHE -S
Date: 2025.06.09 14:19:43 -04'00'
Tanisha Hithe
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
Page 4
FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
510(k) Number (if known): K250465
Device Name: CO2 Laser Machine (Lume)
Indications for Use (Describe):
The CO2 Laser Machine (Lume) is used for body soft tissue vaporization and coagulation in dermatology and plastic surgery, general surgery, gynecology.
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.
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Page 5
510(K) Summary # K250465
1. Submitter's Identification
Owner's Name: Nanjing Bestview Laser S&T Co.,Ltd.
Address: 1st&2nd Floor, Building5, Area1, Phase2, Liandong U Valley Science and Technology Innovation Park, No.1Hengyi Road, Nanjing Economic and Technological Development Zone, Nanjing 210000, Jiangsu, P.R. China
Phone: +86-15824831075
E-mail: jingwang@bestviewlaser.com
Contact: Wang Jing
2. Name of the Device
- Trade/Proprietary Name: CO2 Laser Machine
- Common Name: Powered Laser Surgical Instrument
- Model: Lume
- Classification: II
- Product Code: GEX
3. Device Description
The CO2 Laser Machine generate a 10,600nm wavelength, which is absorbed by water in the tissue.
The laser energy heats up the water until it reaches a boiling point causing the evaporation of the affected tissue. Some heat is absorbed by tissue adjacent to the ablated target area, causing tissue coagulation which induces hemostasis (the cessation of bleeding) as well as thermal stimulation of deep skin layers, which induces fibroblast stimulation and neocollagenesis (the formation of new collagen).
4. Indication for Use
The CO2 Laser Machine (Lume) is used for body soft tissue vaporization and
Page 6
coagulation in dermatology and plastic surgery, general surgery, gynecology.
5. Technological Characteristics of Device as to Compare to the Predicate Devices
| Item | Proposed Device | Predicate Device 1 | Predicate Device 2 | Remark |
|---|---|---|---|---|
| Trade Name | CO2 Laser Machine | CO2 Laser Therapy System | EdgeOne CO2 Laser | / |
| Model | Lume | HS-411 | / | / |
| 510(k) Number | K250465 | K201109 | K162169 | / |
| Product Code | GEX | GEX | GEX | Same |
| Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Same |
| Class | II | II | II | Same |
| Intended Use | The CO2 Laser Machine is used for body soft tissue vaporization and coagulation in dermatology and plastic surgery, general surgery, gynecology. | The CO2 Laser Therapy System is used for body soft tissue vaporization and coagulation in dermatology and plastic surgery, general surgery, gynecology. | 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), gynaecology, 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. | Same |
| Where Used | Hospital | Hospital | Hospital | Same |
| Laser Type | RF tube laser | RF Sealed-off CO2 | CO2 | Same |
| Wavelength | 10600nm | 10600nm | 10600nm | Same |
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| Item | Proposed Device | Predicate Device 1 | Predicate Device 2 | Remark |
|---|---|---|---|---|
| Aiming Beam Wavelength | 650nm/≤390μw /Diode Laser (Red) | 650nm/ |