(216 days)
Not Found
No
The summary describes a standard CO2 laser device and its components, with no mention of AI, ML, or related concepts like image processing or performance metrics typically associated with AI/ML algorithms.
Yes
The device is indicated for dermatological procedures requiring ablation, resurfacing, and coagulation of soft tissue, which are therapeutic applications.
No
The "Intended Use / Indications for Use" states that the device is "indicated for use in dermatological procedures requiring ablation, resurfacing and coagulation of soft tissue," which are therapeutic procedures, not diagnostic ones.
No
The device description explicitly lists multiple hardware components including semiconductor solid-state lasers, switching power supply, laser power, treatment handle, key switch, and cooling system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "dermatological procedures requiring ablation, resurfacing and coagulation of soft tissue." This describes a therapeutic or surgical procedure performed directly on a patient's body, not a test performed on a sample taken from the body (which is the definition of an in vitro diagnostic).
- Device Description: The device is a CO2 laser, which is a medical device used for surgical and therapeutic purposes. It does not involve the analysis of biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis
Therefore, this CO2 Laser is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CO2 Laser (10600nm) is indicated for use in dermatological procedures requiring ablation, resurfacing and coagulation of soft tissue.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The CO2 Laser consists of semiconductor solid-state lasers, switching power supply, laser power, treatment handle, key switch, cooling system and accessories. The CO2 Laser produces a beam of coherent infrared light with 10600nm wavelength.
The CO2 laser comprises five models: YILIYA-10600AH, YILIYA-10600AL, YILIYA-10600CH, Aeslight-10600EH, Aeslight-Ultra peel; their technical parameters and functions are the same, the only difference is their appearances and sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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)
The CO2 Laser and its application comply with standards as detailed in section 9, 11 and 17 of this premarket notification. Therefore, Beijing Honkon states that the non-clinical tests determined that the CO2 Laser to be as safe, as effective and performance is substantially equivalent to the predicate device(s).
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
K13183
| HONKON |
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| 北京宏强富瑞技术有限公司 |
510(k) Premarket Notification Submission
JAN 2 2 2014
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510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | 18 June, 2013 |
|---|---|
| Submitter: | Beijing Honkon Technologies Co., Ltd. |
| Address: No.3 Building, No.11 Yard, Kangding Street, BDA, | |
| 100176, Beijing, P.R.China | |
| Primary Contact Person: | Mike Gu |
| Address: 7th floor, Jingui Business Building, 982 Congyun Road, | |
| Baiyun District, 510420, Guangzhou, China | |
| OSMUNDA Medical Device Consulting Co., Ltd. | |
| Tel: (+86) 20 6232 1333 | |
| Fax:(+86) 208633 0253 | |
| Secondary Contact Person: | Zhao Li |
| Management representative | |
| Beijing Honkon Technologies Co., Ltd. | |
| Tel: (+86) 10-56370050 | |
| Fax: (+86) 10-56370076-610 | |
| Trade Name: | CO2 Laser (10600nm) |
| Common/Usual Name: | CO2 Laser |
| Regulatory Number: | 878.4810 |
| Regulation Name: | Laser surgical instrument for use in general and plastic surgery |
| and in dermatology | |
| Product Code: | GEX |
| Predicate Device(s): | K080496 |
| Device Description: | The CO2 Laser consists of semiconductor solid-state lasers, |
| switching power supply, laser power, treatment handle, key | |
| switch, cooling system and accessories. The CO2 Laser produces | |
| a beam of coherent infrared light with 10600nm wavelength. | |
| The CO2 laser comprises five models: YILIYA-10600AH, YILIYA- | |
| 10600AL, YILIYA-10600CH, Aeslight-10600EH, Aeslight-Ultra | |
| peel; their technical parameters and functions are the same, the | |
| only difference is their appearances and sizes. | |
| Intended Use: | The CO2 Laser (10600nm) is indicated for use in dermatological |
| procedures requiring ablation, resurfacing and coagulation of | |
| soft tissue. |
Confidential and Privileged. This document contains contidential and privileged trade secrets and other information of Beijing Contridential and i Whileged. "This document contribution the provinced by Beijing Honkon Technologies Co., Ltd. All rights reserved
1
Image /page/1/Picture/1 description: The image shows a logo with the word "HONKON" in bold, black letters on the top line. Below the word, there is a line of Chinese characters that reads "北京宏强富瑞技术有限公司". The text is enclosed in a rectangular box.
510(k) Premarket Notification Submission
Technology: The CO2 laser therapy device emits a highly focused laser beam. Absorbed by water of the soft tissue, the CO2 laser incorporating the advanced technologies can immediate ablate discrete columns of tissue without charring. This device can be used in multiple specialties, such as Oral Surgery, Plastic Surgery, Dermatology.
| Determination
of Substantial
Equivalence: | Specification | Predicate Device
K080496 | Proposed
CO2 Laser |
|-------------------------------------------------|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| | Manufacturer | Lutronic Corporation | Honkon |
| | Intended Use | It is indicated for use in dermatological procedures requiring ablation (removal), resurfacing and coagulation of soft tissue. | The CO2 Laser is indicated for use in dermatological procedures requiring ablation (removal), resurfacing and coagulation of soft tissue. |
| | Energy output | 2-240mj | 2-200mj |
| | Laser transfer method | Articulated Arm with Handpiece | Articulated Arm with Handpiece |
| | CO₂ RF Module
Maximum Power | Maximum 30w at continuous wave | Maximum 30w at continuous wave |
| | Wavelength (nm) | 10600 | 10600 |
| | Pulse duration (ms) | 5-100 | 5-100 |
| | Frequency (Hz) | 10-200Hz | 10-200Hz |
| | Patient contacting materials | Aluminum | Aluminum |
| | Compatibility with environment and other devices | Comply with the IEC 60601-1-2 | Comply with the IEC 60601-1-2 |
| | Electrical Safety | Comply with the IEC 60601-1 | Comply with the IEC 60601-1 |
| | Radiation Safety | IEC 60825-1;
IEC 60601-2-22 | IEC 60825-1;
IEC 60601-2-22 |
| | Biocompatibility | ISO 10993-5;
ISO 10993-10 | ISO 10993-5;
ISO 10993-10 |
Confidential and Privileged. This document contidential and privileged trade secrets and other information of Heijing Honkon Technologies Co., Ltd. and as such may not be disclosed to others not employed by Beijing Honkon Technologies Co., Ltd. All rights reserved
19
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| 510(k) Premarket Notification Submission | ||
|---|---|---|
| Other: Device | ||
| Specific Guidance | ||
| Requirements for | ||
| Comparison | Guidance on the Content and | |
| Organization of a Premarket | ||
| Notification for a Medical | ||
| Laser; | ||
| 21 CFR 1040.10 | Guidance on the Content and | |
| Organization of a Premarket | ||
| Notification for a Medical | ||
| Laser; | ||
| 21 CFR 1040.10 |
- The CO2 Laser and its application comply with standards as detailed in section 9, 11 Conclusion: and 17 of this premarket notification. Therefore, Beijing Honkon states that the non-clinical tests determined that the CO2 Laser to be as safe, as effective and performance is substantially equivalent to the predicate device(s).
Confidential and Privileged. This document confidential and privileged trade secrets and other information of Beijing Honkon Technologies Co., Ltd. and as such may not be disclosed to others not employed by Beijing Honkon Technologies Co., Ltd. All rights reserved
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
January 22, 2014
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Osmunda Medical Device Consulting Co., Ltd. Mike Gu Regulatory Affairs Manager 7th floor. Jingui Business Building, 982 Congyun Road, Baiyun District, 510420, Guangzhou, China
Re: K131837
Trade/Device Name: CO2 Laser 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 15, 2014 Received: January 17, 2014
Dear Mr. Gu:
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.
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 803); good manufacturing practice requirements as set
4
Page 2 - Mr. Mike Gu
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
Joshua CDNhipper-S
For
Dr. Binita Ashar Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Premarket Notification Submission
510(k) Number: K131837
Device Name: CO2 Laser (10600nm)
.
Indications for Use:
The CO2 Laser (10600nm) is indicated for use in dermatology procedures requiring ablation,
resurfacing and coagulation of soft tissue.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use_ . (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R Ogden -S 2014.01.21 13:10:40
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(Division Sign-Off) for BSA Division of Surgical Devices K131837 S10(k) Number __