(34 days)
Not Found
No
The document describes a microprocessor-controlled CO2 laser system for surgical applications and does not mention any AI or ML capabilities.
Yes.
The device is used in various medical specialties (dermatology, plastic surgery, general surgery, gynecology, podiatry, dental, and otorhinolaryngology) for procedures like ablation, vaporization, excision, incision, and coagulation of soft tissue, which directly treats or modifies the body.
No
The device is described as a CO2 medical laser system intended for surgical applications such as ablation, vaporization, excision, incision, and coagulation of soft tissue. These are therapeutic actions, not diagnostic ones.
No
The device description explicitly states it is a "microprocessor-controlled CO2 laser system" with components like a sealed laser tube, power supply, laser emission and delivery system, cooling system, and safety features, indicating it is a hardware 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 that the device is used for surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue. These are direct surgical interventions on the patient's body.
- Device Description: The description confirms it's a CO2 laser system designed to deliver light energy for surgical procedures.
- 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 used to perform tests on samples taken from the body to provide diagnostic information. This device is a surgical tool used directly on the patient.
N/A
Intended Use / Indications for Use
The ATL Family of CO2 Medical Laser Systems (and the delivery accessories that are used to deliver laser energy) are indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology,
Dermatology, Plastic Surgery and General Surgery procedures including but not limited to -
- A Treatment of furrows and wrinkles
- A Removal of skin tags, actinic keratosis, acne scars, keloids, tattoos, telangiectasia, squamous and basel cell carcinoma, warts and uneven pigmentation,
- A Treatment of cysts, abscesses, hemorrhoids and other soft tissue applications.
- A Blepharoplasty
- V Site preparation for hair transplants
Dental procedure including but not limited to
- ア Periodontal procedures such as - gingivectomy, removal of hyperplasias, gingivonlasty (incision and excision)
-
Oral Surgery procedures such as - aphous ulcer excision, frenectorny, benignimalignant 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 - - ア Treatment of leukoplakia of larynx, nasal obstruction, rhinophyma, verrucae vulgares, choanal atresia, LAUP and papillomatosis polyps.
Gynecology - V Treatment of condyloma acuminata, cervical intracpithelial neoplasia, leukoplakia and vulvar/vaginal intraepithelial neoplasia, cervical dysplasja.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The ATL Family of CO2 Medical Laser Systems is a microprocessor-controlled CO2 laser system using a sealed laser tube providing either 15 watts maximum power (ATL-150) or 25 watts maximum power (ATL-250).
The ATL Family of CO2 Medical Laser Systems is intended to be used to deliver 10.6um CO2 light energy in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties.
The ATL Farnily of CO2 Medical Laser Systems covers control system, user interface, power supply, laser emission and delivery system, cooling system and safety features.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, skin, gingiva, oral cavity, nail, larynx, nasal passages, cervix, vulva, vagina
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. ATL Family of CO2 Medical 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): 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.
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Image /page/0/Picture/1 description: The image shows the logo for Advanced Technology Laser Co., LTD. The logo includes the company's initials, ATL, in a stylized font inside of a circle. Below the company name is the text "510(k) Summary".
FEB = 2 2009
I 2
Exhibit #B 510(k) Summary
ATL Family of CO2 Medical Laser Systems Advanced Technology Laser Co., Ltd
(As required by 21 CFR 807.92)
- Date Prepared: November 4, 2008
2. Sponsor Information
Advanced Technology Laser Co .; Ltd 920 Jian-chuan Road, Bldg. A2, Level 5 Shanghai, 200240, China
Contact Person Mingxia Xi, Director for Regulatory Affairs Phone: (+86) 21 5471-2151 Fax: (+86) 21 5471-2152
3. Submission Correspondent
Ms. Diana Hong
Mr. Lee Fu
Shanghai Mid-Link Business Consulting Co., Ltd Suite 8D, 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
4. Proposed Device Information
Device Common or Usual Name: Carbon dioxide laser;
Device Trade or Proprietary Name: ATL Family of CO2 Medical Laser Systems; Model: ATL-150, ATL-250;
Classification Name: laser instrument, surgical, powered;
1
Image /page/1/Picture/0 description: The image shows a logo with the letters "ATL" in a stylized, bold font. The letters are arranged in a slightly overlapping manner, with the "A" on the left, the "T" in the middle, and the "L" on the right. The entire logo is enclosed within a circle, with a small portion of the circle missing at the bottom. The logo appears to be a simple, yet distinctive design.
ADVANCED TECHNOLOGY LASER CO., LTD. 510(k) Summary
Regulation Number: 21 CFR 878.4810; Product Code: GEX
Panel: 878 General and Plastic Surgery
5. Predicate Device
SLIM Evolution Family of CO2 Lasers and Delivery Device Accessories (K063001)
6. Device Description
The ATL Family of CO2 Medical Laser Systems is a microprocessor-controlled CO2 laser system using a sealed laser tube providing either 15 watts maximum power (ATL-150) or 25 watts maximum power (ATL-250).
The ATL Family of CO2 Medical Laser Systems is intended to be used to deliver 10.6um CO2 light energy in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties.
The ATL Farnily of CO2 Medical Laser Systems covers control system, user interface, power supply, laser emission and delivery system, cooling system and safety features.
7. Intended Use
The ATL Family of CO2 Medical Laser Systems (and the delivery accessories that are used to deliver laser energy) are indicated for use in surgical applications requiring the ablation, vaporization, excision, and coagulation of soft tissue in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology,
6. Substantial Equivalence
The ATL Family of CO2 Medical Laser Systems share the same indications for use and safety compliance, similar design features, functional features, and therefore are substantially equivalent to the predicate device, the SLIM Evolution Family of CO2 Lascrs and Delivery Device Accessories (K063001). In addition, a review of the predicate device demonstrate that the ATL Family of CO2 Medical Laser Systems is safe and effective as the predicate device as they share
2
Image /page/2/Picture/0 description: The image shows a logo with the letters "ATL" inside of a circle. The letters are stylized and appear to be connected. The logo has a slightly distressed or textured appearance, as if it has been printed or stamped. The circle is not perfectly smooth, adding to the overall vintage or worn look of the design.
ADVANCED TECHNOLOGY LASER CO., LTD. 510(k) Summary
equivalent wavelengths, and are used to perform the same indicated surgical procedures. Therefore the proposed device is substantially equivalent (SE) to the predicate device.
7. Testing
The ATL Family of CO2 Medical Laser Systems 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 Part 1: 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.
Non-Clinical Conclusion:
Laboratory testing was conducted to validate and verify that the proposed device. ATL Family of CO2 Medical System met all design specifications and was substantially equivalent to the predicate device.
Clinical Conclusion: No Clinical Information is required.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Public Health Service
FEB = 2 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Advanced Technology Laser Co., Ltd % Underwriters Laboratories, Inc. Mr. Morten Simon Christensen 455 E. Trimble Road San Jose, California 95131-1230
Re: K083918
Trade/Device Name: ATL Family of CO2 Medical Laser Systems Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: January 16, 2009
Received: January 23, 2009
Dear Mr. Christensen:
We have reviewed vour 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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); good manufacturing practice requirements as set
4
Page 2 - Mr. Morten Simon Christensen
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050,
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours.
Mark M. Millerson
- Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
ADVANCED TECHNOLOGY LASER CO., LTD. 510(k) Submission Report - Indications for Use Statement
Section II Indications for Use Statement
്കാം വേണ്ടിക്കുന്നത്. അവലംബം കോട്ടിക വിക്കുന്നത്. കാലക്കുന്നത് ഇവ കാലത്തിലെ സമ്മാനമായിരുന്നു. അവലംബം സമ്മാനമായ സമ
510(k) Number: Device Name:
ATL Family of CO2 Medical Laser Systems
Indications for Use:
The ATL Family of CO2 Medical Laser Systems (and the delivery accessories that are used to deliver laser energy) are indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.
Dermatology, Plastic Surgery and General Surgery procedures including but not limited to -
- A Treatment of furrows and wrinkles
- A Removal of skin tags, actinic keratosis, acne scars, keloids, tattoos, telangiectasia, squamous and basel cell carcinoma, warts and uneven pigmentation,
- A Treatment of cysts, abscesses, hemorrhoids and other soft tissue applications.
- A Blepharoplasty
- V Site preparation for hair transplants
Dental procedure including but not limited to
- ア Periodontal procedures such as - gingivectomy, removal of hyperplasias, gingivonlasty (incision and excision)
-
Oral Surgery procedures such as - aphous ulcer excision, frenectorny, benignimalignant 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 - -
ア Treatment of leukoplakia of larynx, nasal obstruction, rhinophyma, verrucae vulgares, choanal atresia, LAUP and papillomatosis polyps.
Gynecology
- V Treatment of condyloma acuminata, cervical intracpithelial neoplasia, leukoplakia and vulvar/vaginal intraepithelial neoplasia, cervical dysplasja.
1
| Prescription Use | X | AND/OR | Over-The-Counter 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 ODRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Page 1 of 1
Division of General, Restorative, and Neurological Devices
510(k) Number 1108351Y