(73 days)
Intended Use: The Nd: Yag Laser Therapy Systems 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:
-Tattoo removal: light ink (red, tan, purple, orange, skyblue, green)
-Removal of Epidermal Benign Pigmented Lesions
-Removal of Minor Benign Vascular Lesions including but not limited to telangiectasias
-Treatment of Lentigines
-Treatment of Cafe-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
Nd:Yag Laser Therapy Systems is a kind of laser pigment treatment instrument. It uses the principle of "photo-blasting". The laser emits high energy instantaneously, causing the pigment particles to absorb the laser energy and rapidly expand and rupture. Part of the pigment is broken down into smaller particles and excreted from the body, and the other part is swallowed by human macrophages and excreted through the lymphatic system.
The Nd: Yag laser therapy systems is mainly composed of a host, an operating hand tool and a foot switch. The operation hand is a treatment hand. The host is composed of a power module, a control module and a display module.
I apologize, but I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text.
The document you provided is an FDA 510(k) clearance letter and an associated 510(k) Summary for a Nd:Yag Laser Therapy System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving specific performance criteria through clinical studies in the way you've described for, for example, an AI/ML software as a medical device.
Here's why the requested information isn't present in this document:
- Type of Device: This is a laser hardware device, not an AI/ML algorithm. The performance evaluation focuses on physical parameters (wavelength, pulse energy, etc.) and compliance with electrical, EMC, and laser safety standards.
- 510(k) Process: The 510(k) pathway (Traditional, Abbreviated, or Special) primarily relies on demonstrating that the new device is "substantially equivalent" to a predicate device. This often involves comparing technological characteristics, intended use, and non-clinical performance data (like compliance with recognized standards).
- Lack of Clinical Studies: The "10. Clinical Test Conclusion" section explicitly states: "No clinical study is included in this submission." This means there was no human clinical trial to assess the device's effectiveness or safety in patients, which would typically be required for an AI/ML device to demonstrate performance against acceptance criteria in a real-world scenario.
- No AI/ML Specifics: There's no mention of AI/ML, image analysis, diagnostic performance metrics (like sensitivity, specificity, AUC), or human reader studies (MRMC, standalone algorithm performance) because this device does not perform those functions.
Therefore, the document does not contain the information required to answer your specific questions regarding acceptance criteria, test sets, ground truth establishment, expert adjudication, or MRMC studies for an AI/ML device.
The tables provided (Table 1: General Comparison, Table 2: Performance Comparison, Table 3: Safety Comparison) compare the characteristics of the proposed device to a predicate device and a reference device to demonstrate substantial equivalence, focusing on physical and safety parameters, not diagnostic or AI performance.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
November 2, 2023
Beijing UNT Technology Co., Ltd. % Rav Wang General Manager Beijing Believe-Med Technology Service Co., Ltd. Rm. 912, Building #15, XiYueHui, No.5, YiHe North Rd. FangShan District Beijing, 102401 China
Re: K232532
Trade/Device Name: Nd:Yag Laser Therapy Systems 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: August 21, 2023 Received: August 21, 2023
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 (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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
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For comprehensive regulatory information about mediation-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,
Tanisha L. Tanisha L. Hithe -S 2023.11.02 Hithe -S 14:10:48 -04'00'
Tanisha Hithe 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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Indications for Use
510(k) Number (if known) K232532
Device Name Nd:Yag Laser Therapy Systems
| Indications for Use (Describe) | |
|---|---|
| Intended Use: | The Nd: Yag Laser Therapy Systems 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: | |
| -Tattoo removal: light ink (red, tan, purple, orange, skyblue, green) | |
| -Removal of Epidermal Benign Pigmented Lesions | |
| -Removal of Minor Benign Vascular Lesions including but not limited to telangiectasias | |
| -Treatment of Lentigines | |
| -Treatment of Cafe-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 | |
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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The assigned 510(k) Number: K232532
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.
-
- Date of Submission: 2023/10/26
-
- Sponsor Identification
Beijing UNT Technology Co., Ltd
M2-1 Area, Xinggu Development Zone, Pinggu District, Beijing, China 101200
Contact Person: Qianwen Sheng Position: Deputy General Manager of Technology Tel: +86-10-61960002 Email: shengqianwen@untlaser.com
-
- Designated Submission Correspondent
Mr. Ray Wang
- Designated Submission Correspondent
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, 102401, China
Tel: +86-18910677558 Fax: +86-10-56335780 Email: information@believe-med.com
-
- Identification of Proposed Device
Trade Name: Nd: Yag Laser Therapy Systems
- Identification of Proposed Device
Common Name: Powered Laser Surgical Instrument
Regulatory Information Classification Name: Powered Laser Surgical Instrument Classification: II Product Code: GEX Regulation Number: 878.4810
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Review Panel: General & Plastic Surgery
- న్. Identification of Predicate Device(s)
510(k) Number: K193477 Product Name: Nd:YAG Laser Therapy Systems Manufacturer: Beijing Kes Biology Technology Co., Ltd.
- Device Description:
Nd:Yag Laser Therapy Systems is a kind of laser pigment treatment instrument. It uses the principle of "photo-blasting". The laser emits high energy instantaneously, causing the pigment particles to absorb the laser energy and rapidly expand and rupture. Part of the pigment is broken down into smaller particles and excreted from the body, and the other part is swallowed by human macrophages and excreted through the lymphatic system.
The Nd: Yag laser therapy systems is mainly composed of a host, an operating hand tool and a foot switch. The operation hand is a treatment hand. The host is composed of a power module, a control module and a display module.
-
- Indication For Use Statement:
Intended Use: The Nd: Yag Laser Therapy Systems is indicated for the incision, excision, ablation, vaporization of soft tissues for general dermatologic and general surgical procedures for coagulation and hemostasis.
- Indication For Use Statement:
532nm wavelength:
-Tattoo removal: light ink (red, tan, purple, orange, skyblue, green)
-Removal of Epidermal Benign Pigmented Lesions
-
-Removal of Minor Benign Vascular Lesions including but not limited to telangiectasias
-Treatment of Lentigines -
-Treatment of Cafe-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
- Substantially Equivalent (SE) Comparison 8.
Table 1 General Comparison
| Item | Proposed Device | Predicate Device K193477 | Remark | Reference DeviceK202758 |
|---|---|---|---|---|
| Device Name | Nd:Yag Laser Therapy Systems | ND:YAG Laser Therapy Systems | / |
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| ClassificationRegulation | 21 CFR 878.4810 | 21 CFR 878.4810 | SAME | 21 CFR 878.4810 |
|---|---|---|---|---|
| ClassificationPanel | General & PlasticSurgery | General & Plastic | SAME | General & Plastic |
| Class | II | II | SAME | II |
| Product Code | GEX | GEX | SAME | GEX |
| Common Name | Powered Laser Surgical Instrument | Powered Laser Surgical Instrument | SAME | Powered Laser Surgical Instrument |
| Indication foruse | Intended Use: The Nd: Yag LaserTherapy Systems is indicated forthe incision, excision, ablation,vaporization of soft tissues forgeneral dermatology, dermatologicand general surgical procedures forcoagulation and hemostasis.532nm wavelength:-Tattoo removal: light ink (red, tan,purple, orange, skyblue, green)-Removal of Epidermal BenignPigmented Lesions-Removal of Minor BenignVascular Lesions including but notlimited to telangiectasias-Treatment of Lentigines-Treatment of Cafe-Au-Lait-Treatment of Seborrheic Keratoses-Treatment of Post InflammatoryHyper-Pigmentation-Treatment of Becker's Nevi,Freckles and Nevi Spilus1064nm wavelength:-Tattoo removal: dark ink (black,blue and brown)-Removal of Nevus of Ota-Removal or lightening of unwantedhair with or without adjuvantpreparation.-Treatment of Common Nevi-Skin resurfacing procedures for thetreatment of acne scars and wrinkle | The device is indicated for theincision, excision, ablation,vaporization of soft tissues forgeneraldermatology, dermatologic andgeneral surgical procedures forcoagulation and hemostasis.532nm wavelength:-Tattoo removal: light ink (red, tan,purple, orange, skyblue, green)-Removal of Epidermal BenignPigmented Lesions-Removal of Minor BenignVascular Lesions including but notlimited to telangiectasias-Treatment of Lentigines-Treatment of Cafe-Au-Lait-Treatment of Seborrheic Keratoses-Treatment of Post InflammatoryHyper-Pigmentation-Treatment of Becker's Nevi,Freckles and Nevi Spilus1064nm Wavelength:-Tattoo removal: dark ink (black,blue and brown)-Removal of Nevus of Ota-Removal or lightening of unwantedhair with or without adjuvantpreparation.-Treatment of Common Nevi-Skin resurfacing procedures for thetreatment of acne scars and wrinkle | SAME | The Nd: YAG Laser TherapySystems is intended for usein tattoo removal, treatmentof benign vascular lesions,treatment of benignpigmented lesions, incision,excision,ablation,vaporization of soft tissuefor general dermatology asfollows:532nm wavelength:-Removal of light ink (red,sky blue, green, purple, andorange) tattoo-Treatment of benignvascular lesions including,but not limited to:telangiectasias,-Treatment of benignepidermal pigmented lesionsincluding, but not limited to:cafe-au-lait, solar lentiginos,senile lentiginos, Becher's,nevi Freckles, Nevus spilus,Seborrheic Keratoses-Treatment of PostInflammatoryHyper-Pigmentation1064nm wavelength:-Removal dark ink (black,blue and brown) tattoo-Removal of benign dermalpigmented lesions including,but not limited to: Nevus ofOTA, Common Nevi, andMelasma, |
| -Removal or lightening ofunwanted hair with orwithout adjuvant preparation-Skin resurfacing proceduresfor the treatment of acnescars and wrinkles | ||||
| Prescription useor not | Prescription use | Prescription use | SAME | Prescription use |
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Table 2 Performance Comparison
| ITEM | Proposed Device | Predicate Device | Remark | Reference DeviceK202758 |
|---|---|---|---|---|
| Wavelength (nm) | 1064nm and 532nm | 1064nm and 532nm | SAME | 1064 nm532 nm |
| Aiming beamwavelength | 650nm | 635nm | Analysis | 650 nm |
| Aiming laseroutput power | <5mW | 5mW | SAME | / |
| Laser outputmode | Q-switched pulse | Q-switched pulse | SAME | Q-switched pulse |
| Maximum pulseenergy | 1000mj | @1064nmwavelength:1600mJ@532nm wavelength:400mJ | Analysis | 1000mJ for 1064nm500mJ for 532nm |
| Pulse Duration | 4ns-6ns | 5-10ns | Analysis | 4ns-6ns |
| Spot Size | 2~5mm | 2mm-10mm | Analysis | 2-10mm |
| Fluence range | 1.02-31.80j/cm2for1064nm0.50-15.90j/cm2for532nm | 1064nm 0.4-51.0 J/cm2532nm 0.4-12.7 J/cm2 | Analysis | 1.27 - 31.8 J/cm2 for 1064nm0.6 - 15.9 J/cm2 for 532nm |
| Repetition rate | 1~10hz | 1-6Hz | Analysis | 10 Hz Max. |
| Patient contactmaterial | Aluminum | Aluminum alloy, ABS | Analysis | / |
Table 3 Safety Comparison
| ITEM | Proposed Device | Predicate Device | Remark | Reference Device K202758 |
|---|---|---|---|---|
| Electrical Safety | Comply with ANSI/AAMIES60601-1 | Comply withIEC 60601-1 | SAME | Comply withIEC 60601-1 |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | SAME | Comply with IEC60601-1-2 |
| Laser Safety | Comply with IEC 60601-2-22,IEC 60825-1 | Comply with IEC 60601-2-22 | SAME | Comply with IEC60601-2-22, IEC 60825-1 |
| Biocompatibility | ||||
| Cytotoxicity | No Cytotoxicity | No Cytotoxicity | SAME | / |
| Irritation | No evidence of Irritation | No evidence of Irritation | SAME | / |
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| Sensitization | No evidence of Sensitization | No evidence of Sensitization | SAME | / |
|---|---|---|---|---|
| --------------- | ------------------------------ | ------------------------------ | ------ | --- |
Analysis:
Different - Aiming beam wavelength
The proposed device has different Aiming beam wavelength from the predicate device.
For the difference on Aiming beam wavelength between the predicate and proposed device(s), we can see that the proposed device has similar Aiming beam wavelength with predicate device (K193477). They are only with minor difference. And we think this minor difference will not affect the effectiveness and safety.
And the purpose of aiming beam is only for aiming. And at the same power, the difference in the wavelength of the aiming beam will only cause differences in visual color and brightness, and will not affect the effectiveness and safety. And aiming beam with a wavelength of 650nm is also common in laser products.
Different - Maximum pulse energy
The proposed device has different Maximum pulse energy from the predicate device.
The difference on Output Energy would not impact the safety and effectiveness, because the final safety and effectiveness about clinical indications will depends on the amount of energy output per unit area, which would produce thermal effects to the patient's skin area irradiated to achieve claimed indication for use. And the proposed device has passed the IEC60601-1 test, IEC60601-1-2 test, IEC60601-2-22 test, IEC60825-1 test and performance test, the safety of the product can be ensured.
In addition, the reference device K202758 we have listed has the similar intended use as the proposed device, and the maximum pulse energy of reference device K202758 is consistent with the proposed device. Therefore, we believe that the maximum pulse energy of 1000mJ for 1064nm is a mature parameter that will not affect the safety and effectiveness of the equipment.
Different - Pulse Duration
The proposed device has different Pulse Duration from the predicate device.
Pulse Duration of proposed device is within the predicate device. And the proposed device has passed the
IEC60601-1 test, IEC60601-1-2 test, IEC60601-2-22 test, IEC60825-1 test and performance test, the safety and performance of the product can be ensured.
Different - Spot size
The proposed device has different Spot size from the predicate device.
The difference on Spot size would not impact the safety and effectiveness, because the final safety and effectiveness about clinical indications will depends on the amount of energy output per unit area, which would produce thermal effects to the patient's skin area irradiated to achieve claimed indication for use. And the proposed device has passed the IEC60601-1-2 test. IEC60601-1-2 test. IEC60601-2-22 test, IEC60825-1 test and performance test, the safety of the product can be ensured.
Different - Fluence range
The proposed device has different fluence range from the predicate device.
For the difference on fluence range between the predicate and proposed device(s), we can see that the
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proposed device has similar fluence range with predicate device (K193477). The fluence range of 1064nm is within the predicate device. And the fluence range of 532mm only with minor difference. And we think this minor difference will not affect the effectiveness and safety. And the proposed device has passed the IEC60601-1 test, IEC60601-1-2 test, IEC60601-2-22 test, IEC60825-1 test and performance test, the safety and performance of the product can be ensured.
In addition, the reference device K202758 we have listed has the similar intended use as the proposed device, and the fluence range of reference device K202758 is also similar with the proposed device. The reference device has the same upper limits of the energy for 1064nm/532mm with the proposed device. And the lower limit of the energy for 1064nm/532nm is almost identical with the proposed device. Therefore, we believe that the fluence range of proposed device is a mature parameter that will not affect the safety and effectiveness of the equipment.
Different - Repetition rate
The proposed device has different Repetition rate from the predicate device.
Repetition rate of proposed device is higher than the predicate device. We think the effectiveness of the proposed device can be ensured. And the proposed device has also passed the IEC60601-1 test, IEC60601-1-2 test, IEC60601-2-22 test, IEC60825-1 test and performance test, the safety and performance of the product can be ensured.
In addition, the reference device K202758 we have listed has the similar intended use as the proposed device, and the repetition rate of the reference device K202758 is also 10Hz Max. The proposed device has the same repetition rate with the reference device. Therefore, we believe that the repetition rate 1-10Hz is a mature parameter that will not affect the safety and effectiveness of the equipment.
Different - Patient contact material
The proposed device has different patient contact material from the predicate device.
We have conducted the biocompatibility test included the cytotoxicity test, irritation test and sensitization test according to the judgment of 10993-1. Therefore, this difference will not affect safety and effectiveness of the proposed device.
-
- Non-Clinical Test Conclusion
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:
- Non-Clinical Test Conclusion
-
IEC 60601-1 Edition 3.2 2020-08, Medical electrical equipment Part 1: General requirements for A basic safety and essential performance
-
IEC 60601-1-2 Edition 4.1 2020-09, Medical Electrical Equipment-Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility-Requirements And Tests
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-
IEC 60825-1:2014, Safety of laser products - Part 1: Equipment classification, and requirements
-
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
- 》 ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
ISO 10993-10 Fourth edition 2021, Biological evaluation of medical devices - Part 10: Tests for skin sensitization
♪ ISO 10993-23 First edition 2021-01, Biological evaluation of medical devices - Part 23: Tests for irritation
-
- Clinical Test Conclusion
No clinical study is included in this submission.
- Clinical Test Conclusion
- Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate device ND:YAG Laser Therapy Systems (K193477).
§ 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.