(56 days)
No
The summary describes a laser therapy system with standard components and functions for dermatological procedures. There is no mention of AI, ML, image processing, or any data-driven decision-making processes.
Yes.
The device is used for medical treatments such as tattoo removal, treatment of vascular and pigmented lesions, and skin resurfacing procedures, which are considered therapeutic interventions.
No
The device description and intended use indicate it is used for treatment (tattoo removal, lesion treatment, soft tissue ablation) through laser therapy, not for diagnosing conditions.
No
The device description explicitly lists multiple hardware components, including a laser, power supplies, and a light arm module.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that this device is a laser therapy system used for direct treatment of the human body (tattoo removal, treatment of lesions, soft tissue ablation, etc.).
- The device description focuses on the physical components and function of a laser system. It does not mention any components or processes related to analyzing biological samples.
- The performance studies described are related to electrical safety, laser safety, and software validation, not the analytical or clinical performance of an IVD.
Therefore, this device falls under the category of a therapeutic device, not an IVD.
N/A
Intended Use / Indications for Use
The Nd: YAG Laser Therapy Systems is intended for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesion, ablation, vaporization of soft tissue for general dermatology as follows: 532nm wavelength:
- Removal of light ink (red. sky blue, green, purple, and orange) tattoo
- Treatment of benign vascular lesions including, but not limited to: telangiectasias,
- Treatment of benign epidermal pigmented lesions including, but not limited to: cafe-au-lait, solar lentiginos, senile lentiginos, Becher's, nevi Freckles, Nevus spilus, Seborrheic Keratoses ( Treatment of Post Inflammatory Hyper-Pigmentation 1064nm wavelength:
- Removal dark ink (black, blue and brown) tattoo
- Removal of benign dermal pigmented lesions including, but not limited to: Nevus of OTA, Common Nevi, and Melasma.
- Removal or lightening of unwanted hair with or without adjuvant preparation
- Skin resurfacing procedures for the treatment of acne scars and wrinkles
Product codes
GEX
Device Description
The Nd: YAG Laser Therapy Systems is intended for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesions, incision, excision, ablation, vaporization of soft tissue for general dermatology.
The Nd: YAG Laser Therapy Systems includes five modules described as following: Control Panel
The module uses the microcontroller as the heart, utilizes the LCD screen to display all prompt information and the system state information to complete the human-machine interaction function, and realizes the device parameters setting and accurate control of the output laser energy by the operator.
Main Control Module
The module uses the microcontroller as the heart, receives the laser energy parameters and work command from the control panel and detects the state of footswitch and interlock switch; Controls the work state of laser RF power supply; Uploads the alarm information of footswitch and interlock switch during system working.
Auxiliary Control Module
The module is mainly composed of bi-color indicator and super-quiet adjustable air pump and other components; its working state is determined by the command from the main control module to meet the device requirements, and independently monitor the DC power module output.
Laser, laser RF power supply and DC power supply module
The module completes the YAG laser emission according to the command from the control panel.
Light arm module
The light arm module is the output part of the device, which consists of a socket for light arm, a light arm, the joint for light arm, a hard film reflector and a focusing lens and a handpiece
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
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)
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- IEC 60601-1:2005/A1:2012 Medical Electrical Equipment Part 1: General ● Requirements For Basic Safety And Essential Performance;
- . IEC 60601-2-22:2012, 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.
- . IEC 60601-1-2:2014, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility- Requirements and tests.
In Addition, the following non-clinical tests were performed to make sure that the device performs as intended:
- Software Validation & Verification Test as following: .
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.
No clinical study is performed to support substantial equivalence.
Key results: The maximum fluences of proposed device are way smaller than the proposed device would not raise the risk relating to safety, because the smaller fluences means smaller thermal risk. But smaller raise will raise the concerns about of the other two reference devices with same indication for use and similar specification with proposed device in comparison, K122922 and K113588. Which means the cleared devices (K12922 and K11358) with or smaller maximum influence could achieve the indication for use same with the roposed device. Which is demonstration of that the maximum fluence its indication for use without effectiveness concerns.
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 16, 2020
Shangdong Huamei Technology Co., Ltd. % Rav Wang General Manager Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHei, No.5, YiHe North Rd., FangShan District Beijing, Beijing 102401 China
Re: K202758
Trade/Device Name: Nd: YAG Laser Therapy Systems HM-YL900 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 18, 2020 Received: September 21, 2020
Dear Ray 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. 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 located 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
1
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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-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/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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,
Purva Pandya Acting 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
2
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) K202758
Device Name
Nd: YAG Laser Therapy Systems Model: HM-YL900
Indications for Use (Describe)
The Nd: Y AG Laser Therapy Systems is intended for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesion, ablation, vaporization of soft tissue for general dermatology as follows: 532nm wavelength: * Removal of light ink (red. sky blue, green, purple, and orange) tattoo * Treatment of benign vascular lesions including, but not limited to: telangiectasias, * Treatment of benign epidermal pigmented lesions including, but not limited to: cafe-au-lait, solar lentiginos, senile lentiginos, Becher's, nevi Freckles, Nevus spilus, Seborrheic Keratoses ( Treatment of Post Inflammatory Hyper-Pigmentation 1064nm wavelength: * Removal dark ink (black, blue and brown) tattoo * Removal of benign dermal pigmented lesions including, but not limited to: Nevus of OTA, Common Nevi, and Melasma. * Removal or lightening of unwanted hair with or without adjuvant preparation * Skin resurfacing procedures for the treatment of acne scars and wrinkles
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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3
510(k) Summary
This 510(k) Summary is submitted in accordance with the requirements of 21 CFR Section 807.92.
- Date of Preparation 1. 11/06/2020
-
- Applicant Name and Address Shangdong Huamei Technology Co., Ltd. No. 588, Changning Street, High-tech District, WeiFang, ShanDong, China, 261205
-
- Contact Person Information Xu QingHua General Manager Tel: 86-536-2110001 Fax: 86-536-2109823 Email: xuqh(@yeah.net
-
- Submission Correspondent
Mr. Ray Wang Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing City, China, 102401 Tel: +86-18910677558 Fax: +86-10-56335780 Email: ray.wang@believe-med.com
-
- Identification of Proposed Device
Trade Name: Nd: YAG Laser Therapy Systems, Model: HM-YL900 Common Name: Powered Laser Surgical Instrument Model(s): HM-YL900
- Identification of Proposed Device
Classification Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Class: II Product Code: GEX Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Review Panel: General & Plastic Surgery
-
- Identification of the Predicate and Reference Devices
Primary Predicate 510(k) Number: K190936 Device Name: Q-Switched Nd: YAG Laser System Manufacturer: Shanghai Apolo Medical Technology Co., Ltd.
- Identification of the Predicate and Reference Devices
4
Reference Device #1 510(k) Number: K122922 Product Name: E-beam Nd: YAG Laser System Manufacturer: ECLIPSE AESTHETICS, LLC
Reference Device #2 510(k) Number: K113588 Product Name: SPECTRA LASER SYSTEM Manufacturer: LUTRONIC CORPORATION
-
- Device Description
The Nd: YAG Laser Therapy Systems is intended for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesions, incision, excision, ablation, vaporization of soft tissue for general dermatology.
- Device Description
The Nd: YAG Laser Therapy Systems includes five modules described as following: Control Panel
The module uses the microcontroller as the heart, utilizes the LCD screen to display all prompt information and the system state information to complete the human-machine interaction function, and realizes the device parameters setting and accurate control of the output laser energy by the operator.
Main Control Module
The module uses the microcontroller as the heart, receives the laser energy parameters and work command from the control panel and detects the state of footswitch and interlock switch; Controls the work state of laser RF power supply; Uploads the alarm information of footswitch and interlock switch during system working.
Auxiliary Control Module
The module is mainly composed of bi-color indicator and super-quiet adjustable air pump and other components; its working state is determined by the command from the main control module to meet the device requirements, and independently monitor the DC power module output.
Laser, laser RF power supply and DC power supply module
The module completes the YAG laser emission according to the command from the control panel.
Light arm module
The light arm module is the output part of the device, which consists of a socket for light arm, a light arm, the joint for light arm, a hard film reflector and a focusing lens and a handpiece
-
- Indications for Use
The Nd: YAG Laser Therapy Systems is intended for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesions, incision, excision,
- Indications for Use
5
ablation, vaporization of soft tissue for general dermatology as follows: 532nm wavelength:
- Removal of light ink (red, sky blue, green, purple, and orange) tattoo ●
- Treatment of benign vascular lesions including, but not limited to: telangiectasias,
● Treatment of benign epidermal pigmented lesions including, but not limited to: cafe-au-lait, solar lentiginos, senile lentiginos, Becher's, nevi Freckles, Nevus spilus, Seborrheic Keratoses
-
Treatment of Post Inflammatory Hyper-Pigmentation
1064nm wavelength: -
Removal dark ink (black, blue and brown) tattoo
-
Removal of benign dermal pigmented lesions including, but not limited to: Nevus of OTA, Common Nevi, and Melasma,
-
Removal or lightening of unwanted hair with or without adjuvant preparation ●
-
Skin resurfacing procedures for the treatment of acne scars and wrinkles
6
9. Substantially Equivalent (SE) Comparison
| ITEM | Proposed Device | Predicate Device K190936 | Reference Device K122922 | Reference Device K113588 | Remark |
|---|---|---|---|---|---|
| Product Code | GEX | GEX | GEX | GEX | SAME |
| Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | SAME |
| Class | 2 | 2 | 2 | 2 | SAME |
| Where used | hospital | hospital | hospital | hospital | SAME |
| Indication For Use | The Nd: YAG Laser Therapy Systems is | ||||
| intended for use in tattoo removal, | |||||
| treatment of benign vascular lesions, | |||||
| treatment of benign pigmented lesions, | |||||
| incision, excision, ablation, vaporization of | |||||
| soft tissue for general dermatology as | |||||
| follows: | |||||
| 532nm wavelength: | |||||
| Removal of light ink (red, sky | |||||
| blue, green, purple, and orange) tattoo Treatment of benign vascular | |||||
| lesions including, but not limited | |||||
| to: telangiectasias, Treatment of benign epidermal | |||||
| pigmented lesions including, but | |||||
| not limited to: cafe-au-lait, solar | |||||
| lentiginos, senile lentiginos, | |||||
| Becher's, nevi Freckles, Nevus | |||||
| spilus, Seborrheic Keratoses Treatment of Post | |||||
| Inflammatory Hyper- | |||||
| Pigmentation 1064nm wavelength: | |||||
| Removal dark ink (black, blue | |||||
| and brown) tattoo Removal of benign dermal | |||||
| pigmented lesions including, but | |||||
| not limited to: Nevus of OTA, | |||||
| Common Nevi, and Melasma, Removal or lightening of | |||||
| unwanted hair with or without | |||||
| adjuvant preparation Skin resurfacing procedures for | |||||
| the treatment of acne scars and | The Q-Switched Nd: YAG Laser System is | ||||
| intended for use in tattoo removal, | |||||
| treatment of benign vascular lesions, | |||||
| treatment of benign pigmented lesions, | |||||
| incision, excision, ablation, vaporization of | |||||
| soft tissue for general dermatology as | |||||
| follows: | |||||
| 532nm wavelength (nominal delivered | |||||
| energy of 585nm and 650nm with optional | |||||
| dye handpiece): | |||||
| Removal of light ink (red, sky blue, | |||||
| green, purple, and orange) tattoo Treatment of benign vascular lesions | |||||
| including, but not limited to: | |||||
| telangiectasias, Treatment of benign epidermal | |||||
| pigmented lesions including, but not | |||||
| limited to: cafe-au-lait, solar | |||||
| lentiginos, senile lentiginos, Becher's, | |||||
| nevi Freckles, Nevus spilus, | |||||
| Seborrheic Keratoses Treatment of Post Inflammatory | |||||
| Hyper-Pigmentation 1064nm wavelength: | |||||
| Removal dark ink (black, blue and | |||||
| brown) tattoo Removal of benign dermal pigmented | |||||
| lesions including, but not limited to: | |||||
| Nevus of OTA, Common Nevi, and | |||||
| Melasma, Removal or lightening of unwanted | |||||
| hair with or without adjuvant | |||||
| preparation Skin resurfacing procedures for the | The Tri-Beam Nd: YAG Laser System in | ||||
| indicated for: the incision, excision, | |||||
| ablation, vaporization of soft tissues for | |||||
| general dermatology, dermatologic and | |||||
| general surgical procedures for | |||||
| coagulation and hemostasis. | |||||
| 532nm Wavelength (nominal delivered | |||||
| energy of 585 nm and 650 nm with | |||||
| optional dye handpieces): | |||||
| -Tattoo removal: light ink (red, tan, | |||||
| purple, orange, sky blue, green) - Removal of Epidermal Pigmented | |||||
| Lesions -Removal of Minor Vascular Lesions | |||||
| including but not limited to | |||||
| telangiectasias -Treatment of Lentigines; -Treatment of Café-Au-Lait -Treatment of Seborrheic Keratoses - Treatment of Post Inflammatory Hyper- | |||||
| Pigmentation -Treatment of Becker's Nevi, Freckles | |||||
| and Nevi Spilus 1064nm Wavelength: | |||||
| -Tattoo removal: dark ink (black, blue | |||||
| and brown) -Removal of Nevus of Ota -Removal or lightening of unwanted hair | |||||
| with or without adjuvant preparation. - Treatment of Common Nevi -Skin resurfacing procedures for the | |||||
| treatment of acne scars and wrinkle | The SPECTRA Laser System is | ||||
| indicated for the incision, excision, | |||||
| ablation, vaporization of soft tissues | |||||
| for general dermatology, dermatologic | |||||
| and general surgical procedures for | |||||
| coagulation and hemostasis. | |||||
| 532nm Wavelength (nominal | |||||
| delivered energy of 585 nm and 650 | |||||
| nm with optional dye handpieces): | |||||
| -Tattoo removal: light ink (red, tan, | |||||
| purple, orange, sky blue, green) - Removal of Epidermal Pigmented | |||||
| Lesions -Removal of Minor Vascular Lesions | |||||
| including but not limited to | |||||
| telangiectasias -Treatment of Lentigines -Treatment of Café-Au-Lait -Treatment of Seborrheic Keratoses - Treatment of Post Inflammatory | |||||
| Hyper | |||||
| -Pigmentation -Treatment of Becker's Nevi, Freckles | |||||
| and Nevi Spilus 1064nm Wavelength: | |||||
| -Tattoo removal: dark ink (black, blue | |||||
| and brown) -Removal of Nevus of Ota -Removal | |||||
| or lightening of unwanted hair with or | |||||
| without adjuvant preparation. - Treatment of Common Nevi -Skin resurfacing procedures for the | |||||
| treatment of acne scars and wrinkle - | |||||
| Treatment of melasma | SAME |
Tab 1 General Comparison
7
| wrinkles | treatment of acne scars and wrinkles | ||||
|---|---|---|---|---|---|
| Tab 2 Performance Comparison | |||||
| ITEM | Proposed Device | Predicate Device K190936 | Reference Device K122922 | Reference Device K113588 | Remark |
| Laser Medium | Nd:YAG | Nd:YAG | Nd:YAG | Nd:YAG | SAME |
| Wavelength | 1064 nm | ||||
| 532 nm | 1064 nm | ||||
| 532 nm | 1064 nm | ||||
| 532 nm | 1064 nm | ||||
| 532 nm | SAME | ||||
| Aiming Beam | |||||
| Wavelength | 650 nm | 650 nm | 655 nm | 655 nm | SAME |
| Output energy | 1000mJ for 1064nm | ||||
| 500mJ for 532nm | 1200mJ for 1064nm | ||||
| 500mJ for 532nm | 1200mJ for 1064nm | ||||
| 400mJ for 532nm | 1200mJ for 1064nm | ||||
| 400mJ for 532nm | Analysis | ||||
| Fluence | 1.27 - 31.8 J/cm2 for 1064nm | ||||
| 0.6 - 15.9 J/cm2 for 532nm | 1.52 - 152.9 J/cm2 for 1064nm | ||||
| 0.6 - 63.7 J/cm2 for 532nm | 2.38-38.21J/cm2 for 1064nm | ||||
| 0.6-1.42 J/cm2 for 532 nm | 3.12-16.98J/cm2 for 1064nm | ||||
| 0.4-12.7 J/cm2 for 532 nm | Analysis | ||||
| Spot Size | 2-10mm | 1-10mm | 2-8 mm for 1064 nm | ||
| 6-9mm for 532 nm | 3,4,5,6,7,8 mm | Similar | |||
| Pulse Width | 4ns-6ns | 4ns-6ns | 5-10ns | 5-10ns | SAME |
| Frequency | 10 Hz Max. | 10 Hz Max. | 10Hz Max. | 10Hz Max. | SAME |
| Laser Class | Class 4 | Class 4 | Class 4 | Class 4 | SAME |
Difference Analysis
There difference in Output Energy, Spot Size and Fluence between the proposed device and predicate (reference) device(s).
The difference on Output Energy and Spot Size would effectiveness, because the final safety and effectiveness about clinical indications will depends on the anount of energy output per unit area, which would produce themal its skin area irradiated o achive indication for use.
For the difference on Fluence listed between the showe, we can see that the proposed device has similar minimum filence with predicate device (K190936), 1.27 Jon2 (for 1064 mm) and 0.6 J/cm2 (for 532 mm), they are same and only with miner difference for 1064nm.
The major difference is maximum fluence bevice and with predicate device (K190936), 31.80cm2 VS. 152.9 7cm2 (for 1064 mm) and 1.5.9 I cm2 VS. 63.7 J (for 532mm). The maximum fluences of proposed device are way smaller than the proposed device would not raise the risk relating to safety, because the smaller fluences means smaller thermal risk.
But smaller raise will raise the concerns about of the other two reference devices with same indication for use and similar specification with proposed device in comparison, K122922 and K113588.
After comparison in Table 2 above, the maximum fuence for 1064 nm of proposed device K122922, 31.8/on2 VS. 38.21/vm2, and bigger than the reference device K113588. 31.81/cm2 VS. 16.981/cm2.
And in the same way, the maximum fuence for 532 millar with the reference device K11358, 15.9/cm2 VS. 12.71J/cm2, ad similar the reference device K122922, 15.9J/cm2 VS. 1.42J/cm2.
Which means the cleared devices (K12922 and K11358) with or smaller maximum influence could achieve the indication for use same with the roposed device. Which is demonstration of that the maximum fluence its indication for use without effectiveness concerns.
8
Tab 3 Safety Comparison
| Item | Proposed Device | Predicate Device K190936 | Remark | |||||
|---|---|---|---|---|---|---|---|---|
| EMC, Electrical and Laser Safety | ||||||||
| Electrical Safety | Comply with IEC 60601-1, IEC 60601-2- | |||||||
| 22 | Comply with IEC 60601-1, IEC 60601-2- | |||||||
| 22 | SAME | |||||||
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | SAME | |||||
| Laser Safety | Comply with IEC 60601-2-22, IEC 60825 | Comply with IEC 60601-2-22, IEC 60825 | SAME |
10. Non-Clinical Testing
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- IEC 60601-1:2005/A1:2012 Medical Electrical Equipment Part 1: General ● Requirements For Basic Safety And Essential Performance;
- . IEC 60601-2-22:2012, 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.
- . IEC 60601-1-2:2014, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility- Requirements and tests.
In Addition, the following non-clinical tests were performed to make sure that the device performs as intended:
- Software Validation & Verification Test as following: .
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.
11. Clinical Testing
No clinical study is performed to support substantial equivalence.
-
- Conclusion
Based on the comparison and analysis above, the proposed device is determined to be as safe, as effective, and performs as well as the legally marketed predicate and reference devices.
- Conclusion