(73 days)
No
The description focuses on the physical principles of laser operation and standard electrical/mechanical components. There is no mention of AI, ML, image processing, or data-driven decision making.
Yes
The intended use explicitly states "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," which describes therapeutic actions. Furthermore, it details uses like "Tattoo removal," "Removal of Epidermal Benign Pigmented Lesions," and "Skin resurfacing procedures for the treatment of acne scars and wrinkle," all of which are considered therapeutic treatments.
No
Explanation: The "Intended Use" section clearly states the device is "indicated for the incision, excision, ablation, vaporization of soft tissues" and various "treatments" and "removal" procedures. This describes therapeutic actions, not diagnostic ones. The device description also focuses on how it treats pigment. There is no mention of the device being used to identify or analyze a condition.
No
The device description explicitly states it is composed of a host, an operating hand tool, and a foot switch, which are hardware components.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the device is for the "incision, excision, ablation, vaporization of soft tissues" and various dermatological and surgical procedures. These are all procedures performed directly on the patient's body.
- Device Description: The description explains the mechanism of action ("photo-blasting") which involves the laser interacting with pigment particles within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or treatment.
IVDs are specifically designed to analyze samples taken from the body to provide diagnostic or other health-related information. This device is a therapeutic laser used for direct treatment on the patient.
N/A
Intended Use / Indications for 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
Product codes
GEX
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.
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
Prescription Use
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 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:
- 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
- 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
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). 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
1
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.
2
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
3
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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4
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
5
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 Device
K202758 |
|-------------|------------------------------|------------------------------|--------|-----------------------------|
| Device Name | Nd:Yag Laser Therapy Systems | ND:YAG Laser Therapy Systems | / | |
6
| Classification
| Regulation | 21 CFR 878.4810 | 21 CFR 878.4810 | SAME | 21 CFR 878.4810 |
|---|---|---|---|---|
| Classification | ||||
| Panel | General & Plastic | |||
| Surgery | 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 for | ||||
| use | 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 | The device 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 | SAME | 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 wrinkles | ||||
| Prescription use | ||||
| or not | Prescription use | Prescription use | SAME | Prescription use |
7
Table 2 Performance Comparison
| ITEM | Proposed Device | Predicate Device | Remark | Reference Device
K202758 |
|------------------------------|-----------------------------------------------------|-----------------------------------------------------|----------|------------------------------------------------------------|
| Wavelength (nm) | 1064nm and 532nm | 1064nm and 532nm | SAME | 1064 nm
532 nm |
| Aiming beam
wavelength | 650nm | 635nm | Analysis | 650 nm |
| Aiming laser
output power | 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
10
-
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).