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

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, Main Control Module, Auxiliary Control Module, Laser, laser RF power supply and DC power supply module, Light arm module.

AI/ML Overview

The provided text is a 510(k) summary for the "Nd: YAG Laser Therapy Systems Model: HM-YL900." This document primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a dedicated study with outcome measures.

The document discusses non-clinical testing performed to verify compliance with various safety and performance standards for medical electrical equipment and laser products. However, it explicitly states:

"No clinical study is performed to support substantial equivalence."

Therefore, I cannot provide detailed information about acceptance criteria and a study that proves the device meets them in the way typically associated with a clinical trial or performance study. The information below is derived from the non-clinical testing and the comparison tables within the document, rather than a standalone clinical study to establish performance metrics.

Here's an attempt to answer your request based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Since no clinical study with explicit performance acceptance criteria and results is mentioned, the "acceptance criteria" here refer to compliance with recognized standards and similarity to predicate devices' specifications during non-clinical testing. The "reported device performance" refers to the device's technical specifications and its demonstrated compliance with safety and electrical standards.

Note: This table reflects technical specifications and compliance with safety standards, not therapeutic efficacy metrics which would typically be derived from a clinical performance study.

Acceptance Criteria (from recognized standards & predicate comparison)	Reported Device Performance (from non-clinical testing & specifications)
Electrical Safety (IEC 60601-1, IEC 60601-2-22): Device meets basic safety and essential performance requirements.	Complies with IEC 60601-1:2005/A1:2012, IEC 60601-2-22:2012.
Electromagnetic Compatibility (IEC 60601-1-2): Device meets EMC requirements.	Complies with IEC 60601-1-2:2014.
Laser Safety (IEC 60601-2-22, IEC 60825-1): Device meets laser safety requirements and is classified appropriately.	Complies with IEC 60601-2-22:2012, IEC 60825-1:2014. Classified as Class 4 Laser.
Software Validation & Verification: Software is validated and verified to prevent serious patient/operator injury.	Software verification and validation testing conducted; documentation provided as per FDA guidance. Software classified as "major" level of concern.
Wavelength: Operates at 1064 nm and 532 nm.	Operates at 1064 nm and 532 nm.
Aiming Beam Wavelength: Operates at 650 nm.	Operates at 650 nm.
Output Energy: Specified output energy levels for 1064nm and 532nm.	1000mJ for 1064nm; 500mJ for 532nm.
Fluence: Specified fluence range for 1064nm and 532nm.	1.27 - 31.8 J/cm² for 1064nm; 0.6 - 15.9 J/cm² for 532nm.
Spot Size: Specified spot size range.	2-10mm.
Pulse Width: Specified pulse width range.	4ns-6ns.
Frequency: Specified maximum frequency.	10 Hz Max.
Intended Use: For tattoo removal, treatment of benign vascular/pigmented lesions, incision, excision, ablation, vaporization of soft tissue for general dermatology as specified.	Matches the Indications for Use of the predicate devices, demonstrating substantial equivalence in intended use.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not applicable. No clinical test set or human data was used for performance evaluation. The "test set" implies non-clinical tests on the device hardware and software.
Data Provenance: Not applicable for a clinical test set. The data presented is from internal non-clinical testing performed by the manufacturer to demonstrate compliance with standards and equivalence to predicate devices, as well as publicly available information on the predicate devices. The country of origin for the device manufacturer is China.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. There was no clinical test set requiring expert-established ground truth for evaluation of clinical outcomes. The "ground truth" here is compliance with engineering and safety standards, established through testing against those standards.

4. Adjudication method for the test set

Not applicable. No clinical test set requiring adjudication was used.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The device is a laser therapy system, not an AI-assisted diagnostic tool. No MRMC study was performed, and no AI component is described.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, in a non-clinical context. The "standalone" performance here refers to the device's technical specifications and its ability to meet safety and electrical standards independently, as verified through non-clinical testing. This is purely device-centric performance, not a clinical "algorithm only" performance.

7. The type of ground truth used

For the technical and safety performance, the "ground truth" was compliance with established international consensus standards (e.g., IEC 60601-1, IEC 60825-1) and the technical specifications of legally marketed predicate devices.

8. The sample size for the training set

Not applicable. This document describes a physical medical device, not a machine learning model. Therefore, there is no "training set" in the context of AI.

9. How the ground truth for the training set was established

Not applicable. As there is no training set for an AI model, there is no ground truth establishment process for it.

Summary

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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

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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

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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)

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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
1. Applicant Name and Address Shangdong Huamei Technology Co., Ltd. No. 588, Changning Street, High-tech District, WeiFang, ShanDong, China, 261205
1. Contact Person Information Xu QingHua General Manager Tel: 86-536-2110001 Fax: 86-536-2109823 Email: xuqh(@yeah.net
1. 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

1. Identification of Proposed Device
  Trade Name: Nd: YAG Laser Therapy Systems, Model: HM-YL900 Common Name: Powered Laser Surgical Instrument Model(s): HM-YL900

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

1. 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.

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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

1. 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

1. 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,

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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

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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 isintended for use in tattoo removal,treatment of benign vascular lesions,treatment of benign pigmented lesions,incision, excision, ablation, vaporization ofsoft tissue for general dermatology asfollows:532nm wavelength:Removal of light ink (red, skyblue, green, purple, and orange) tattoo Treatment of benign vascularlesions including, but not limitedto: telangiectasias, Treatment of benign epidermalpigmented lesions including, butnot limited to: cafe-au-lait, solarlentiginos, senile lentiginos,Becher's, nevi Freckles, Nevusspilus, Seborrheic Keratoses Treatment of PostInflammatory Hyper-Pigmentation 1064nm wavelength:Removal dark ink (black, blueand brown) tattoo Removal of benign dermalpigmented lesions including, butnot limited to: Nevus of OTA,Common Nevi, and Melasma, Removal or lightening ofunwanted hair with or withoutadjuvant preparation Skin resurfacing procedures forthe treatment of acne scars and	The Q-Switched Nd: YAG Laser System isintended for use in tattoo removal,treatment of benign vascular lesions,treatment of benign pigmented lesions,incision, excision, ablation, vaporization ofsoft tissue for general dermatology asfollows:532nm wavelength (nominal deliveredenergy of 585nm and 650nm with optionaldye handpiece):Removal of light ink (red, sky blue,green, purple, and orange) tattoo Treatment of benign vascular lesionsincluding, but not limited to:telangiectasias, Treatment of benign epidermalpigmented lesions including, but notlimited to: cafe-au-lait, solarlentiginos, senile lentiginos, Becher's,nevi Freckles, Nevus spilus,Seborrheic Keratoses Treatment of Post InflammatoryHyper-Pigmentation 1064nm wavelength:Removal dark ink (black, blue andbrown) tattoo Removal of benign dermal pigmentedlesions including, but not limited to:Nevus of OTA, Common Nevi, andMelasma, Removal or lightening of unwantedhair with or without adjuvantpreparation Skin resurfacing procedures for the	The Tri-Beam Nd: YAG Laser System inindicated for: the incision, excision,ablation, vaporization of soft tissues forgeneral dermatology, dermatologic andgeneral surgical procedures forcoagulation and hemostasis.532nm Wavelength (nominal deliveredenergy of 585 nm and 650 nm withoptional dye handpieces):-Tattoo removal: light ink (red, tan,purple, orange, sky blue, green) - Removal of Epidermal PigmentedLesions -Removal of Minor Vascular Lesionsincluding but not limited totelangiectasias -Treatment of Lentigines; -Treatment of Café-Au-Lait -Treatment of Seborrheic Keratoses - Treatment of Post Inflammatory Hyper-Pigmentation -Treatment of Becker's Nevi, Frecklesand Nevi Spilus 1064nm Wavelength:-Tattoo removal: dark ink (black, blueand brown) -Removal of Nevus of Ota -Removal or lightening of unwanted hairwith or without adjuvant preparation. - Treatment of Common Nevi -Skin resurfacing procedures for thetreatment of acne scars and wrinkle	The SPECTRA Laser System isindicated for the incision, excision,ablation, vaporization of soft tissuesfor general dermatology, dermatologicand general surgical procedures forcoagulation and hemostasis.532nm Wavelength (nominaldelivered energy of 585 nm and 650nm with optional dye handpieces):-Tattoo removal: light ink (red, tan,purple, orange, sky blue, green) - Removal of Epidermal PigmentedLesions -Removal of Minor Vascular Lesionsincluding but not limited totelangiectasias -Treatment of Lentigines -Treatment of Café-Au-Lait -Treatment of Seborrheic Keratoses - Treatment of Post InflammatoryHyper-Pigmentation -Treatment of Becker's Nevi, Frecklesand Nevi Spilus 1064nm Wavelength:-Tattoo removal: dark ink (black, blueand brown) -Removal of Nevus of Ota -Removalor lightening of unwanted hair with orwithout adjuvant preparation. - Treatment of Common Nevi -Skin resurfacing procedures for thetreatment of acne scars and wrinkle -Treatment of melasma	SAME

Tab 1 General Comparison

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	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 nm532 nm	1064 nm532 nm	1064 nm532 nm	1064 nm532 nm	SAME
Aiming BeamWavelength	650 nm	650 nm	655 nm	655 nm	SAME
Output energy	1000mJ for 1064nm500mJ for 532nm	1200mJ for 1064nm500mJ for 532nm	1200mJ for 1064nm400mJ for 532nm	1200mJ for 1064nm400mJ for 532nm	Analysis
Fluence	1.27 - 31.8 J/cm2 for 1064nm0.6 - 15.9 J/cm2 for 532nm	1.52 - 152.9 J/cm2 for 1064nm0.6 - 63.7 J/cm2 for 532nm	2.38-38.21J/cm2 for 1064nm0.6-1.42 J/cm2 for 532 nm	3.12-16.98J/cm2 for 1064nm0.4-12.7 J/cm2 for 532 nm	Analysis
Spot Size	2-10mm	1-10mm	2-8 mm for 1064 nm6-9mm 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.

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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.

1. 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.

Regulation Number and Section

§ 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.