(224 days)
No
The summary describes a laser system with different configurations and mentions standard performance testing, but there is no mention of AI, ML, image processing, or data sets for training or testing algorithms.
Yes
The device is indicated for the treatment of various benign cutaneous and pigmented lesions, as well as tattoo removal, which are therapeutic applications.
No
The device is indicated for the treatment of various lesions and tattoo removal, not for diagnosis.
No
The device description explicitly states it is a "laser system" and mentions different models with varying configurations, indicating it is a hardware device that delivers laser energy. The performance studies also include tests related to hardware characteristics like spot size accuracy and thermal energy distribution.
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 for the treatment of various skin conditions and tattoo removal. IVDs are used for the diagnosis of diseases or conditions.
- Mechanism of Action: The device uses a laser to treat lesions and remove tattoos. This is a therapeutic action, not a diagnostic one.
- Device Description: The description details a laser system, which is a therapeutic device.
- Lack of Diagnostic Information: There is no mention of analyzing samples (like blood, urine, or tissue) or providing diagnostic information.
Therefore, the ND YAG Q-switch Laser Therapy Machine is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ND YAG Q-switch Laser Therapy Machine is indicated for the treatment of: benign cutaneous lesions, such as Warts, Scars, Striae and Psoriasis; benign pigmented lesions, such as Lentigines, nevus, and birthmark; and the removal of black or blue tattoos.
Product codes
GEX
Device Description
The ND YAG Q-switch Laser Therapy Machine is laser system which delivers laser at a wavelength 1064nm or 532nm.
There are 3 models included, FG 2010, FG 2010-B, FG 2010-C, the three models have same intended use, mechanism of action, principle and specification, only differences are the configurations.
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
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 tests were conducted to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- IEC 60601-1:2012 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance;
- IEC 60601-2-22:2007, 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: 2007, Safety of laser products - Part 1: Equipment classification and requirements.
- IEC 60601-1-2:2007, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility-Requirements and tests.
- ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro cytotoxicity
- ISO 10993-10:2002/Amd. 1: 2006, Biological Evaluation of Medical Device, Part 10-Test for irritation and delay-type hypersensitivity AMENDMENT 1
- Performance Testing for Spot Size Accuracy.
- Thermal Energy Distribution Test: determine the difference for thermal energy distribution of proposed device with predicate device.
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 22, 2017
Beijing Adss Development Co., Ltd % Mr. Ray Wang Beijing Believe Technology Service Co., Ltd. 5-1206, Build 332, Dafangju No. 25 Banbidian Rd. LiYuan Town, Tongzhou District, Beijing, 101121 China
Re: K161926 Trade/Device Name: Nd Yag Q-switch Laser Therapy Machine 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 18, 2017 Received: January 23, 2017
Dear Mr. 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. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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 Industry and Consumer Education at its toll-free 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" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Jennifer R. Stevenson -S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K161926
Device Name ND YAG O-switch Laser Therapy Machine
Indications for Use (Describe)
The ND YAG Q-switch Laser Therapy Machine is indicated for the treatment of: benign cutaneous lesions, such as Warts, Scars, Striae and Psoriasis; benign pigmented lesions, such as Lentigines, nevus, and birthmark; and the removal of black or blue tattoos.
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
Tab #3 510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: K161926
-
- Date of Preparation
02/16/2017
- Date of Preparation
-
Sponsor 2.
Beijing ADSS Development Co., Ltd
F6, Xiandao Bldg., Jinyuan Rd. 36, Daxing Economic Development zone, Beijing, China, 102628
Establishment Registration Number: Not yet registered or the Number Contact Person: Gao Yurong Position: sales manager Tel: 86-10-83625120 Fax:86-10-83625121 Email: gyr@adss.com.cn
- Submission Correspondent 3.
Mr. Ray Wang
Beijing Believe Technology Service Co., Ltd. 5-1206, Build 332, DaFangJu, No.25 BanBiDian Rd., LiYuan Town, TongZhou District, Beijing, 101121, China
Tel: +86-18910677558 Fax: +86-10-52214696 Email: ray.wang@believe-med.com
4
-
- Identification of Proposed Device
Trade Name: ND YAG Q-switch Laser Therapy Machine Common Name: Powered Laser Surgical Instrument Model(s): FG 2010, FG 2010-B, FG 2010-C
- Identification of Proposed Device
Regulatory Information: Classification Name: Powered Laser Surgical Instrument Classification: II; Product Code: GEX; Regulation Number: 21 CFR 878.4810; Review Panel: General& Plastic Surgery;
Intended Use:
The ND YAG Q-switch Laser Therapy Machine is indicated for the treatment of: benign cutaneous lesions, such as Warts, Scars, Striae and Psoriasis; benign pigmented lesions, such as Lentigines, nevus, and birthmark; and the removal of black or blue tattoos.
-
- Device Description
The ND YAG Q-switch Laser Therapy Machine is laser system which delivers laser at a wavelength 1064nm or 532nm.
- Device Description
There are 3 models included, FG 2010, FG 2010-B, FG 2010-C, the three models have same intended use, mechanism of action, principle and specification, only differences are the configurations. The detailed difference shown as following:
| Model | FG2010 | FG2010-B | FG2010-C |
|---|---|---|---|
| Size | 860×310×830mm | 800×320×920mm | 830×320×830mm |
| Weight | 60kg | 65kg | 60kg |
Table 1 The Difference of Models
| Table 2 Main Components introduction | ||
|---|---|---|
| -------------------------------------- | -- | -- |
| Component name | Function |
|---|---|
| Main unit | Main Interface |
| Articulated Arm | Articulated arm for holding of Treatment Probe |
| Treatment Probe | Laser Deliver |
| Foot Pedal | control pulse light output |
5
-
- Identification of Predicate Device
Predicate Device: 510(k) Number K072564
- Identification of Predicate Device
Predicate Device Name Harmony XL Multiple Application Platform
Manufacturer
Alma Laser, Ltd
-
- Non-Clinical Test
Non clinical tests were conducted to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- Non-Clinical Test
-
IEC 60601-1:2012 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance;
-
IEC 60601-2-22:2007, 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: 2007, Safety of laser products - Part 1: Equipment classification and requirements.
-
IEC 60601-1-2:2007, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility-Requirements and tests.
-
ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro cytotoxicity
-
ISO 10993-10:2002/Amd. 1: 2006, Biological Evaluation of Medical Device, Part 10-Test for irritation and delay-type hypersensitivity AMENDMENT 1
-
Performance Testing for Spot Size Accuracy.
-
Thermal Energy Distribution Test: determine the difference for thermal energy distribution of proposed device with predicate device.
-
- Clinical Test
No clinical study is included in this submission.
6
9. Substantially Equivalent (SE) Comparison
| ITEM | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| Product Code | GEX | GEX | SE |
| Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 | SE |
| Class | 2 | 2 | SE |
| Intended Use | The ND YAG Q-switch Laser Therapy | ||
| Machine is indicated for the treatment of: | |||
| benign cutaneous lesions, such as Warts, | |||
| Scars, Striae and Psoriasis; benign | |||
| pigmented lesions, such as Lentigines, | |||
| nevus, and birthmark; and the removal of | |||
| black or blue tattoos. | The 1064 nm Long Pulsed and Q-switched | ||
| Nd:YAG Laser Module Handpieces | |||
| The 1064 nm Nd:YAG Laser Module | |||
| handpiece (Long Pulsed and Q-switched | |||
| with and without contact-cooling) are | |||
| indicated for treatment and clearance of | |||
| Benign vascular lesions such as, but | |||
| not limited to treatment of: Port wine stains Hemangiomas Warts Superficial and deep | |||
| telangiectasias (venulectasias) Reticular veins (0.1-4.0 mm | |||
| dia.) of the leg Rosacea Venus lake Leg veins Spider veins Angiomas Benign cutaneous lesions, such as, | |||
| but not limited to : Warts Scars Striae Psoriasis Benign pigmented lesions such as, | |||
| but not limited to: Lentigos (age spots) Solar lentigos (sun spots) Café-au- lait birthmarks Seborrheic keratoses Nevi and nevus of Ota Chloasma Verrucae | SE |
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| > Skin tage | |
|---|---|
| > Keratoses | |
| > The removal of black, blue or | |
| green tattoos (significant | |
| reduction in the intensity of | |
| black and /or blue tattoos) | |
| > Plaques | |
| • | Pigmented lesions to reduce lesion |
| size, for patients with lesions that | |
| would potentially benefit from | |
| aggressive treatment, and for patients | |
| with lesions that have not responded | |
| to other laser treatments. | |
| • | The non-ablative treatment of facial |
| wrinkles, such as, but not limited to: | |
| > Periocular wrinkles | |
| > Perioral wrinkles | |
| • | Laser skin resurfacing procedures for |
| the treatment of: | |
| > Acne scars | |
| > Wrinkles | |
| • | Reduction of red pigmentation in |
| hypertrophic and keloid scars where | |
| vascularity is an integral part of the | |
| scar. | |
| Indicated for use on all skin types | |
| (Fitzpatrick I-VI), including tanned skin |
Table 4 Performance Comparison
| ITEM | Proposed Device | Predicate Device 2
K072536 | Remark |
|---------------------------|---------------------------------------------|-------------------------------|----------|
| Laser Medium | Nd:YAG | Nd:YAG | SE |
| wavelength | 1064 nm
532 nm | 1064 nm
532 nm | SE |
| Output energy | 100-1000mJ for 1064nm
50-500mJ for 532nm | 400-1200mJ | SE |
| Max.
Energy
Density | 31.8J/cm²
15.9 J/cm² | 16.9 J/cm² | SE |
| Spot Size | 2-10mm | 3, 5 mm | Analysis |
8
| Pulse Width | 5ns-8ns | 20 ns | Analysis |
|---|---|---|---|
| Repetition Rate | 1-10 Hz | 1, 2, 4 Hz | Analysis |
| Disinfection | Disinfect the handpiece before and | ||
| after every treatment by 75% | |||
| medicinal alcohol | --- | Analysis | |
| Laser Class | Class 4 | Class 4 | SE |
| Cooling | |||
| method | |||
| for treated skin | |||
| area | N.A. | N.A. | SE |
| Aiming Beam | Red Laser, |