(90 days)
Not Found
No
The summary describes a standard IPL system based on selective thermolysis and does not mention any AI/ML components or capabilities.
No.
While the device is used for aesthetic and surgical applications, its primary indications are permanent hair removal and reduction of benign lesions, which are not typically classified as therapeutic interventions. The IEC standard 60601-2-57:2011 explicitly mentions "non-laser light source equipment intended for therapeutic, diagnostic, monitoring, cosmetic and aesthetic use", indicating that cosmetic and aesthetic uses, like permanent hair removal, are distinct from therapeutic uses.
No
The device description and intended use indicate it is an Intense Pulsed Light Treatment System for permanent hair removal and reduction of benign lesions (surgical and aesthetic applications), not for diagnosing conditions. While one of the performance studies (IEC 60601-2-57:2011) mentions "diagnostic" use for light source equipment, the specific intended use of this device (LK-PT) does not include diagnostic purposes.
No
The device description explicitly states it is an "intense pulsed light system" and details its hardware components and mechanism of action (delivering light at specific wavelengths). The performance studies also focus on electrical and photobiological safety standards relevant to hardware devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for surgical and aesthetic applications on the human body (permanent hair removal, reduction of benign pigmented lesions and benign vascular lesions). This involves direct interaction with the patient's tissues.
- Device Description: The device is an intense pulsed light system that works on the principle of selective thermolysis, applying light energy to target chromophores 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, etc.) in vitro (outside the body) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic or other health-related information. This device is a therapeutic and aesthetic device that directly treats the patient's body.
N/A
Intended Use / Indications for Use
The Intense Pulsed Light Treatment System (Model: LK-PT) is indicated for use in surgical and aesthetic applications in permanent hair removal, reduction of benign pigmented lesions and benign vascular lesions.
Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.
Product codes
ONF
Device Description
The LK-PT device is an intense pulsed light system which delivers intense pulsed light at wavelengths ranging from 560mm ~ 1200nm. Intense Pulsed Light(IPL) system work on the principles of selective thermolysis. That is, causing thermal damage to target chromophores by using light of appropriate wavelength in pulses that exceeds the chromophores' thermal relaxation time but sparing normal skin by limiting the pulse width below the thermal relaxation time for skin.
IPL systems are different from lasers in that they deliver many wavelengths in each pulse of light instead of just one wavelength. Generally, IPL enhances penetration without using excessive energy levels and enables targeting of specific chromophores.
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)
Summary of non-clinical performance Tests
- ANSI AAMI ES60601-1: 2005&A1:2012 &A2:2021: Medical Electrical Equipment -Part 1: General Requirement for Basic Safety and Essential Performance;
- IEC 60601-1-2: 2014+A1:2020, Medical Electrical Equipment - Part 1-2: General Requirement for Basic Safety and Essential Performance- Collateral Standard: Electromagnetic Disturbances- Requirements and Tests;
- IEC 60601-2-57:2011, Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic,monitoring, cosmetic and aesthetic use;
- IEC 62471:2006, Photobiological safety of lamps and lamp systems.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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 shows 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. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 14, 2024
Nanjing Bestview Laser S&T Co., Ltd. Jing Wang Management Representative 1st & 2nd Floor, Building 5, Area 1, Phase 2 Liandong U Valley Science and Technology Innovation Park Nanjing, Jiangsu 210000 China
Re: K242440
Trade/Device Name: Intense Pulsed Light Treatment System (LK-PT) 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: ONF Dated: August 16, 2024 Received: August 16, 2024
Dear Jing 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 (the 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/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 Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
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 820.30 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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.
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-regulatory
2
assistance/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,
Digitally signed by Yan Fu -S
Yan Fu -S Date: 2024.11.14 22:52:51
-05'00'
for 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
Submission Number (if known)
Device Name
Intense Pulsed Light Treatment System (LK-PT)
Indications for Use (Describe)
The Intense Pulsed Light Treatment System (Model: LK-PT) is indicated for use in surgical and aesthetic applications in permanent hair removal, reduction of benign pigmented lesions and benion vascular lesions.
Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.
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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K242440 510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: K242440
1. Date of preparation
August 16, 2024
2. Sponsor
Name: Nanjing Bestview Laser S&T Co., Ltd.
Address: 1st&2nd Floor, Building5, Area1, Phase2, Liandong U Valley Science and
Technology Innovation Park, No.1 Hengyi Road, Nanjing Economic and Technological
Development Zone, Nanjing 210000, Jiangsu, P.R. China
Contact Person: Jing Wang
Position: Management Representative
Phone: +86-15824831075
E-mail: jingwang@bestviewlaser.com
3. Identification of predicate device
510(k) Number: K192521
Trade Name: Intense Pulsed Light Treatment System
Product Code: ONF
Manufacturer: Shangdong Huamei Technology Co., Ltd.
4. Identification of proposed device
Common Name: Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Trade name: Intense Pulsed Light Treatment System
Model: LK-PT.
Regulatory Information:
Classification: Class II
Classification Name: Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
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Regulation: 21CFR 878.4810
Review Panel: General & Plastic Surgery
Product Code: ONF
5.Device Description:
The LK-PT device is an intense pulsed light system which delivers intense pulsed light at wavelengths ranging from 560mm ~ 1200nm. Intense Pulsed Light(IPL) system work on the principles of selective thermolysis. That is, causing thermal damage to target chromophores by using light of appropriate wavelength in pulses that exceeds the chromophores' thermal relaxation time but sparing normal skin by limiting the pulse width below the thermal relaxation time for skin.
IPL systems are different from lasers in that they deliver many wavelengths in each pulse of light instead of just one wavelength. Generally, IPL enhances penetration without using excessive energy levels and enables targeting of specific chromophores.
6.Indications for Use
The Intense Pulsed Light Treatment System (Model: LK-PT) is indicated for use in surgical and aesthetic applications in permanent hair removal, reduction of benign pigmented lesions and benign vascular lesions.
Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.
7. Substantially Equivalent (SE) Comparison
| Item | Proposed Device | Predicate Devices | Remark |
|---|---|---|---|
| Trade Name | Intense Pulsed Light Treatment System | Intense Pulsed Light Treatment System | / |
| Model | LK-PT | HM-IPL-B8 | / |
| 510(k) | |||
| Number | / | K192521 | / |
| Product Code | ONF | ONF | Same |
| Regulation | |||
| No. | 21 CFR 878.4810 | 21 CFR 878.4810 | Same |
| Class | II | II | Same |
| Intended | |||
| Use | The Intense Pulsed Light Treatment System (Model: LK-PT) are indicated for use in surgical and aesthetic applications in permanent hair removal, reduction of benign | The Intense Pulsed Light Treatment System (Model: HM-IPL-B8) are indicated for use in surgical and aesthetic applications in permanent hair | Same |
6
| | pigmented lesions and benign vascular lesions.
Permanent hair reduction is defined as
the long-term, stable reduction in the
number of hairs regrowing when
measured at 6, 9, and 12 months after
the completion of a treatment regimen. | removal, reduction of benign pigmented lesions and benign vascular lesions.
Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen. | |
|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Where Used | Hospital | Hospital | Same |
| Light source | Intense pulsed light | Intense pulsed light | Same |
| Wavelength | 560-1200nm
695-1200nm | 430-1200nm, 530-1200nm,
640-1200nm,
Optional:480-1200nm,
560-1200nm, 590-1200nm,
690-1200nm, 750 -1200nm | Analysis1 |
| Deliver system | Sapphire | Sapphire | SE |
| Energy density | 6-50 J/cm2 | 10-50J/cm² | Analysis2 |
| Pulse Delay | 10-50ms | 5-50ms | Analysis3 |
| Pulse Width | 2-10 ms | 1-20ms | Analysis3 |
| Spot size | 8mm*40 mm | 15mm×50mm; 80mm×40mm; | Analysis4 |
| Max power | 2500W | 2000W | Analysis5 |
(1) Analysis 1: Wavelength
The wavelength range of the LK-PT device is within the wavelength range of the predicate for the indications for use, and the slight difference does not result in a negative effect on safety and effectiveness.
(2) Analysis 2: Energy density
The energy density range of the proposed device covers the energy density range of the predicate device. Although the minimum energy density is lower than the minimum energy density of the predicate device, but the maximum energy density doesn't exceed the maximum energy density of the predicate device.
(3) Analysis 3: Energy density Pulse Delay and Width
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The pulse delay and the pulse width range of the proposed device is within the corresponding range of the predicate for the indications for use, and the slight difference does not result in a negative effect on safety and effectiveness.
(4) Analysis 4: Spot Size
The spot size of the proposed device is different from that of predicate device, but the difference of the spot size is only for different treatment area, and it does not negatively affect the output parameter for treatment.
(5) Analysis 5: Max power
The max power of the proposed device is different from that of predicate device, but the power of the machine refers to the rate at which the machine consumes electrical energy while running, so it will not have much impact on the performance of the machine.
Discussion
The proposed device is different in wavelength, Energy density, Pulse Delay, Pulse width and spot size from the predicate device. By complying with non-clinical test conducted, the proposed device is determined to be substantially equivalency with predicate device.
8. Biocompatibility
The Intense Pulsed Light Treatment System (Model: LK-PT) have been evaluated in accordance with Part 10993 of the International Standard Organization (ISO). Standard tests administered include:
- � ISO 10993-5: 2009 Biological Evaluation of Medical Devices - Part 5: Tests for in vitro cytotoxicity.
- � ISO 10993-10 2021, Biological Evaluation of Medical Devices - Part 10: Tests for Skin sensitization.
- � 10993-23: 2021, Biological Evaluation of Medical Devices - Part 23: Tests for irritation.
9.Summary of non-clinical performance Tests
-
ANSI AAMI ES60601-1: 2005&A1:2012 &A2:2021: Medical Electrical Equipment -Part 1: General Requirement for Basic Safety and Essential Performance;
-
IEC 60601-1-2: 2014+A1:2020, Medical Electrical Equipment - Part 1-2: General Requirement for Basic Safety and Essential Performance- Collateral Standard: Electromagnetic Disturbances- Requirements and Tests;
-
IEC 60601-2-57:2011, Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic,monitoring, cosmetic and aesthetic use;
8
IEC 62471:2006, Photobiological safety of lamps and lamp systems. >
10. Clinical Test Conclusion
No clinical study is included in this submission.
11. Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device.