(105 days)
Not Found
No
The document does not mention AI, ML, or any related concepts like deep learning, neural networks, or image processing for analysis or decision-making. The description focuses on the laser technology and its delivery system.
Yes
The device is clearly indicated for various surgical applications across multiple medical specialties, including the treatment of medical conditions and the modification of body structure, which are definitions of a therapeutic device.
No
The device is described as a CO2 laser system used for surgical applications requiring ablation, vaporization, excision, incision, and coagulation of soft tissue. It is not mentioned to be used for diagnosis.
No
The device description explicitly details hardware components such as a laser emission and delivery system, articulated arm, mirrors, handpieces, control system, user interface, power supply, and cooling system. This is not a software-only device.
Based on the provided information, the eBeam CO2 Laser System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
- eBeam CO2 Laser System Function: The description clearly states that the eBeam CO2 Laser System is used for surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue directly on the patient. It delivers laser energy to the treatment site via an articulated arm and handpiece.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens taken from the patient. Its function is to directly interact with and modify soft tissue.
Therefore, the eBeam CO2 Laser System is a surgical laser device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
eBeam CO2 Laser System is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), general surgery ,gynecology,podiary,dental and otorhinolaryngology
Dermatology, Plastic Surgery and General Surgery procedures including but not limited to:
Laser skin resurfacing
Treatment of furrows and wrinkles
Removal of skin tags, actinic keratosis, acne scars, keloids, tattoos, telangiectasia, squamous and basel cell carcinoma, warts and uneven pigmentation.
Treatment of cysts, abscesses, hemorrhoids and other soft tissue applications.
Blepharoplasty
Site preparation for hair transplants
Dental procedure including but not limited to -
Periodontal procedures such as - gingivectomy, removal of hyperplasias gingivoplasty (incision and excision);
Oral Surgery procedures such as - aphous ulcer excision, frenectomy, benign /malignant lesion ablation, operculectomy and homeostasis
Podiatry procedures including but not limited to -
Ablation, vaporization and excision of soft tissue lesions such as ingrown nail, fungal nail, porokeratoma, matrixectomy and verrucae vulgares.
Otorhinolaryngology (ENT) procedures including but not limited to -
Treatment of leukoplakia of larynx, nasal obstruction, rhinophyma, verrucrea vulgares, choanal atresia, rhinophyma, LAUP and papillomatosis polyps.
Gynecology
Treatment of condyloma acuminata, cervical intraepithelial neoplasia, leukoplakia and vulvar/vaginal intraepithelial neoplasia, cervical dysplasia.
Product codes
GEX
Device Description
eBeam CO2 Laser System is an intelligent sealed-off CO2 laser. eBeam CO2 Laser System delivers laser energy to the treatment site via a 7-joint spring-balanced articulated arm in which mirrors reflect the laser beam along the axis of arms to enter the output device- the specially designed handpiece.
eBeam CO2 Laser System can produce a laser beam with a wavelength of 10.6 m which is effective on all soft tissues, thus it can be used in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic(dermatology and plastic surgery), general surgery, gynecology, podiatry, dental and otorhinolaryngology.
eBeam CO2 Laser System consists of control system, user interface, power supply, laser emission and delivery system, cooling system, safety features and handpieces (including scanning handpiece and normal handpiece).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue (in medical specialties including: aesthetic (dermatology and plastic surgery), general surgery, gynecology, podiatry, dental and otorhinolaryngology)
skin
furrows and wrinkles
skin tags, actinic keratosis, acne scars, keloids, tattoos, telangiectasia, squamous and basel cell carcinoma, warts and uneven pigmentation
cysts, abscesses, hemorrhoids
Blepharoplasty
hair transplants
gingiva
aphous ulcer
frenum
benign/malignant lesion
operculum
ingrown nail, fungal nail, porokeratoma, matrixectomy and verrucae vulgares
leukoplakia of larynx, nasal obstruction, rhinophyma, verrucrea vulgares, choanal atresia, rhinophyma, LAUP and papillomatosis polyps
condyloma acuminata, cervical intraepithelial neoplasia, leukoplakia and vulvar/vaginal intraepithelial neoplasia, cervical dysplasia
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Conclusion:
Laboratory testing was conducted to validate and verify that the proposed device, eBeam CO2 Laser System met all design specifications and was substantially equivalent to the predicate device.
Clinical Conclusion: No Clinical Information is required
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
K101555
SEP 1:7 2010
ADVANCED TECHNOLOGY LASER CO., LTD. 510(k) Submission Report-510(k) summary
Section III. 510(k) summary
eBeam CO2 Laser System
Advanced Technology Laser Co., Ltd
(As required by 21 CFR 807.92)
1. Date Prepared: March 22, 2010
2. Sponsor Information
Advanced Technology Laser Co., Ltd 920 Jian-Chuan Road, Bldg. A2, Level 5 Shanghai, 200240, China
Contact Person: Jing Wang, Registration specialist Phone: +86-21-54712151(ext:837) Fax: +86-21-54712152
3. Submission Correspondent
Ms. Diana Hong Mr. Lee Fu Shanghai Mid-Link Business Consulting Co., Ltd Suite 5D, No.19, Lane 999, Zhongshan No.2 Road(S) Shanghai,200030, China Tel: +86-21-64264467 Fax: +86-21-64264467-809 Email: Diana.hong@mid-link.net
1
ADVANCED TECHNOLOGY LASER CO., LTD. 510(k) Submission Report -510(k) summary
4. Proposed Device Information
Device Common or Usual Name: Carbon dioxide laser; Device Trade or Proprietary Name: eBeam CO2 Laser System Model: eBeam Classification Name: Laser instrument, Surgical, Powered Regulation Number: 21 CFR 878.4810 Product Code: GEX Panel: 878 General and Plastic Surgery
5. Predicate Device
SLIM Evolution Family of CO2 Laser and Delivery Device Accessories (K063001)
6. Device Description
eBeam CO2 Laser System is an intelligent sealed-off CO2 laser. eBeam CO2 Laser System delivers laser energy to the treatment site via a 7-joint spring-balanced articulated arm in which mirrors reflect the laser beam along the axis of arms to enter the output device- the specially designed handpiece.
eBeam CO2 Laser System can produce a laser beam with a wavelength of 10.6 m which is effective on all soft tissues, thus it can be used in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic(dermatology and plastic surgery), general surgery, gynecology, podiatry, dental and otorhinolaryngology.
eBeam CO2 Laser System consists of control system, user interface, power supply, laser emission and delivery system, cooling system, safety features and handpieces (including scanning handpiece and normal handpiece).
7. Intended use
2
ADVANCED TECHNOLOGY LASER CO., LTD. 510(k) Submission Report-510(k) summary
eBeam CO2 Laser System is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), general surgery, gynecology, podiatry, dental and otorhinolaryngology.
8. Substantial Equivalence
eBeam CO2 Laser System shares the same indications for use and safety compliance, similar design features, functional features, and therefore are substantially equivalent to the predicate device, SLIM Evolution Family of CO2 Lasers and Delivery Device Accessories (K063001). In addition, a review of the predicate device demonstrate that eBeam CO2 Laser System is safe and effective as the predicate device as they share equivalent wavelengths, and are used to perform the same indicated surgical procedures. Therefore the proposed device is substantially equivalent (SE) to the predicate device.
9. Testing
eBeam CO2 Laser System is designed, tested and will be manufactured in accordance with both mandatory and voluntary standards, including:
- IEC 60825-1: 2007, Safety of laser products Part 1: Equipment classification, . requirements and user's guide.
- IEC 60601-2-22: 2007, Medical Electrical Equipment Part 2: Particular . requirements for the safety of diagnostic and therapeutic laser equipment.
- IEC 60601-1:1988+A1:1991+A2:1995, Medical Electrical Equipment Partl: ● General requirements for safety.
- IEC60601-1-2:2001+A1:2004, Medical Electrical Equipment Part 1: General ● requirements for safety-2, Collateral Standard: Electromagnetic compatibility -Requirements and tests.
The devices also comply with European Medical Directive 93/42/EEC and the US Federal Performance Standards 21 CFR 1002.10 Requirements (21CFR 1040.10 and 21CFR 1040.11 for Class IV Laser Products), Part 820 - Quality System Regulation, and have passed ISO9001 and ISO13485 System Certification.
3
ADVANCED TECHNOLOGY LASER CO., LTD. 510(k) Submission Report -510(k) summary
Non-Clinical Conclusion:
Laboratory testing was conducted to validate and verify that the proposed device, eBeam CO2 Laser System met all design specifications and was substantially equivalent to the predicate device.
Clinical Conclusion: No Clinical Information is required
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Advanced Technology Laser Co., Ltd. % Underwriters Laboratories, Inc. Laboratory and Testing Mr. Marc M. Mouser 2600 N.W. Lake Road Camas, Washington 98607-9526
SEP 1 7 2010
Re: K101555
Trade/Device Name: eBeam CO2 Laser System 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 08, 2010 Received: September 09, 2010
Dear Mr. Mouser:
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.
5
Page 2 - Mr. Marc M. Mouser
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); good manufacturing practice requirements as set forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
For
Dep D.R
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
×101555 SEP 1 7 2010
DVANCED TECHNOLOGY LASER CO., LTD. 510(k) Submission Report -Indications for Use Statement
Attachment IV Indications for Use Statement
510(k) Number: K101555 Device Name:
eBeam CO2 Laser System
Indications for Use:
eBeam CO2 Laser System are indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), general surgery ,gynecology,podiary,dental and otorhinolaryngology
Dermatology, Plastic Surgery and General Surgery procedures including but not limited to:
Laser skin resurfacing
Treatment of furrows and wrinkles
Removal of skin tags, actinic keratosis, acne scars, keloids, tattoos, telangiectasia, squamous and basel cell carcinoma, warts and uneven pigmentation.
Treatment of cysts, abscesses, hemorrhoids and other soft tissue applications.
Blepharoplasty
Site preparation for hair transplants
Dental procedure including but not limited to -
Periodontal procedures such as - gingivectomy, removal of hyperplasias gingivoplasty (incision and excision);
Oral Surgery procedures such as - aphous ulcer excision, frenectomy, benign /malignant lesion ablation, operculectomy and homeostasis
Over-The-Counter Use Prescription Use _ AND/OR X (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
CDRH. Office of Device Evaluation (ODE) Concurrence of
Neil R. Oyler Co.
Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of 2
510(k) Number. K101555
7
Image /page/7/Picture/0 description: The image shows the logo for Advanced Technology Laser Co., LTD. The logo includes the letters ATL inside of a circle. Below the logo, the text "510(k) Submission Report -Indications for Use Statement" is visible. The text is left-aligned and in a smaller font size than the company name.
Continued from Previous Page
Podiatry procedures including but not limited to -
Ablation, vaporization and excision of soft tissue lesions such as ingrown nail, fungal nail, porokeratoma, matrixectomy and verrucae vulgares.
Otorhinolaryngology (ENT) procedures including but not limited to -
Treatment of leukoplakia of larynx, nasal obstruction, rhinophyma, verrucrea vulgares, choanal atresia, rhinophyma, LAUP and papillomatosis polyps.
Gynecology
Treatment of condyloma acuminata, cervical intraepithelial neoplasia, leukoplakia and vulvar/vaginal intraepithelial neoplasia, cervical dysplasia.
This device is for prescription use only.
The safety and effectiveness of this scanner/device has not been evaluated as a fractionated scanner/device.
AND/OR Over-The-Counter Use Prescription Use _____________________________________________________________________________________________________________________________________________________________ × (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 2 of 2
NielReOgle for mxm
- Orvision of Surgical, Orthopedic, Restorative Devic
510(k) Number K101555