(388 days)
Not Found
No
The summary describes a standard IPL system with different handpieces and wavelength ranges for aesthetic treatments. There is no mention of AI, ML, image processing, or any data-driven decision-making processes that would indicate the use of these technologies.
Yes
The device is intended for the treatment of various medical conditions, including benign pigmented and vascular lesions, which indicates a therapeutic purpose.
No
This device is intended for aesthetic applications (treatment of lesions, hair removal) requiring selective photothermolysis, not for diagnosing conditions. Its purpose is therapeutic, not diagnostic.
No
The device description explicitly states that the system consists of a system console, electronics, cooling system, and two hand pieces, in addition to software. This indicates it is a hardware-based device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states aesthetic applications requiring selective photothermolysis of soft tissue for treating skin lesions and unwanted hair. This involves direct interaction with the patient's body for therapeutic purposes.
- Device Description: The description details a non-invasive system for skin treatments and hair removal using light energy.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological specimens.
The device is a therapeutic device that uses light energy to treat conditions on the skin.
N/A
Intended Use / Indications for Use
The IPL System - KDT750 is intended for use in aesthetic applications requiring selective photothermolysis (photocoagulation or coagulation) of soft tissue in the medical specialties of general and plastic surgery, and dermatology.
Indications for use for IPL System with 515-980nm IPL Handpiece (SR Handpiece).
- · Benign pigmented epidermal and cutaneous lesions including warts, melasma, epithelides (freckles) and lentigines.
- · Benign cutaneous vascular lesions, including port wine stains, facial and truncal telangiectasias, rosacea, erythema of rosacea and poikiloderma of Civatte.
- · For use on skin types(I-V)
Indications for use for IPL System with 640-950nm IPL Handpiece (HR Handpiece).
- · The removal of unwanted hair to effect stable long-term or permanent hair reduction.
- · For use on Fitzpatrick skin types (I-V)
- 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 regime.
Product codes (comma separated list FDA assigned to the subject device)
ONF
Device Description
The IPL System - KDT750 is a multi-wavelength non-invasive system for IPL skin treatments, treatment of vascular and pigmented lesions, and hair removal using two wavelength ranges: 530-950nm and 640-950nm. The IPL System consists of a system console, electronics and software, cooling system, and two hand pieces with different wavelength.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, epidermal, cutaneous, facial, truncal, leg.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Medical specialties of general and plastic surgery, and dermatology.
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)
Clinical testing was not performed for the subject device as part of the submission.
Non-Clinical Tests:
- Electrical Safety and Electromagnetic Compatibility (EMC) according to IEC60601-1:2005+CORR.1:2006+CORR.2:2007+A1:2012, IEC 60601-1-2:2014, IEC 60825-1:2007, IEC 60601-2-57:2011.
- Biocompatibility according to ISO 10993-5:2009 and ISO 10993-10:2010.
The conclusion from the testing is the device is safe and effective for its intended use, and performs as well or better than the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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.
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February 18, 2023
Shanghai Omni Laser Skinology Co., Ltd. % Helen Nan General Manager New Risen Enterprise Management Consulting Co., Ltd. Room 302, Building 3, Hangqian Mansion, Hangqian Street, Lucheng District Wenzhou, Zhejiang 325000 China
Re: K220214
Trade/Device Name: IPL System - KDT750 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: January 19, 2023 Received: January 19, 2023
Dear Helen Nan:
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 Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
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 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.
Jianting Wang -S
Jianting Wang 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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Indications for Use
510(k) Number (if known) K220214
Device Name IPL System - KDT750
Indications for Use (Describe)
The IPL System - KDT750 is intended for use in aesthetic applications requiring selective photothermolysis (photocoagulation or coagulation) of soft tissue in the medical specialties of general and plastic surgery, and dermatology.
Indications for use for IPL System with 515-980nm IPL Handpiece (SR Handpiece).
- · Benign pigmented epidermal and cutaneous lesions including warts, melasma, epithelides (freckles) and lentigines.
- · Benign cutaneous vascular lesions, including port wine stains, facial and truncal telangiectasias, rosacea, erythema of rosacea and poikiloderma of Civatte.
- · For use on skin types(I-V)
Indications for use for IPL System with 640-950nm IPL Handpiece (HR Handpiece).
- · The removal of unwanted hair to effect stable long-term or permanent hair reduction.
- · For use on Fitzpatrick skin types (I-V)
- 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 regime.
| 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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Image /page/3/Picture/0 description: The image shows a green shamrock with three leaves. A blurred, light purple arc surrounds the shamrock, giving the image a sense of motion or a halo effect. The background is white, which makes the green and purple colors stand out.
K220214 510(k) Summary (As required by 21 CFR 807.92)
1.0 Submitter Information
| Company: | Shanghai Omni Laser Skinology Co., Ltd. |
|---|---|
| Address | Floor 3, Building 3, NO. 227, Mingqiang Road |
| Songjiang District, Shanghai, 201612, CHINA | |
| Phone: | +86-021-54847192 |
| E-mail: | avril@omni-laser.com |
| Contact | Avril Ouyang |
| Title: | General Manager |
| • Date of Preparation: Feb. 17, 2023 |
2.0 Device Information
| Trade/Device Name: | IPL System |
|---|---|
| Model: | KDT750 |
| Regulation Description: | Laser surgical instrument for use in general and plastic |
| surgery and in dermatology. | |
| Device: | Powered Light Based Non-Laser Surgical Instrument |
| With Thermal Effect | |
| Review Panel: | General & Plastic Surgery |
| Product Code: | ONF |
| Submission Type: | Traditional 510(k) |
| Regulation Number: | CFR 878.4810 |
| Device Class: | Class II |
3.0 Predicate Device Information
| Trade/Device Name: | Alma Harmony XL Multi-Application Platform |
|---|---|
| 510k Number: | K072564 |
| Submitter: | Alma Lasers, Ltd. |
4.0 Device Description
The IPL System - KDT750 is a multi-wavelength non-invasive system for IPL skin treatments, treatment of vascular and pigmented lesions, and hair removal using two wavelength ranges: 530-950nm and 640-950nm. The IPL System consists of a system console, electronics and software, cooling system, and two hand pieces with different wavelength.
5.0 Indications for Use
The IPL System - KDT750 is intended for use in aesthetic applications requiring selective photothermolysis (photocoagulation or coagulation) of soft tissue in the medical specialties of general and plastic surgery, and dermatology.
Indication for use for the 530-950nm wavelength handpiece (SR Handpiece)
- · Benign pigmented epidermal and cutaneous lesions including warts, melasma, epithelides (freckles) and lentigines.
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Image /page/4/Picture/0 description: The image shows a green shamrock with three leaves. A blurred, light purple arc surrounds the shamrock, creating a circular effect. The shamrock is the focal point, with the arc adding a subtle, decorative element to the design.
- · Benign cutaneous vascular lesions, including port wine stains, facial and truncal telangiectasias, rosacea, erythema of rosacea and poikiloderma of Civatte.
- For use on skin types(I-V).
Indication for use for the 640-950nm wavelength handpiece (HR Handpiece)
- · The removal of unwanted hair to effect stable long-term or permanent hair reduction.
- For use on Fitzpatrick skin types (I-V).
-
- 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 regime.
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Image /page/5/Picture/0 description: The image shows a green three-leaf clover with a light purple arc behind it. The clover is in the center of the image and has a slight shadow effect. The purple arc is positioned behind the clover, creating a sense of depth. The background is white.
6.0 Comparison of Technological Characteristics with the Predicate Device
Table 1 - Comparison table of the Subject device (SR Handpiece) and Predicate device (SSR Module AFT Handpiece)
| Device Feature | IPL System-
SR Handpiece | HarmonyXL-SSR Module AFT
Handpieces | Comparison |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Wavelength | 530-950 nm | 540-950 nm | Note 1 |
| Indications for use | The IPL System - KDT750 is intended for use in aesthetic applications requiring selective photothermolysis (photocoagulation or coagulation) of soft tissue in the medical specialties of general and plastic surgery, and dermatology. Benign pigmented epidermal and cutaneous lesions including warts, melasma, epithelides (freckles) and lentigines. Benign cutaneous vascular lesions, including port wine stains, facial and truncal telangiectasias, rosacea, erythema of rosacea and poikiloderma of Civatte. For use on skin types (I-V). | Intended for use in aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology The treatment of moderate inflammatory acne vulgaris. The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma and ephelides (freckles), lentigines, nevi, melasma, and café-au-lait macules. The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. Use on all skin types (Fitzpatrick I-VI). | Note 2 |
| Light Source | Pulsed light with AFT and EDF | Pulsed light with AFT and EDF | Same |
| Timers | 1, 3, 12 seconds | 1, 3, 30 seconds | Note 3 |
| Energy Density (Fluence) | 1-12 J/cm2 | 1-15 J/cm2 | Same |
| Spot Size | 8*40 mm (3.2 cm2) | 3 cm2 | Same |
| Pulse Repetition Rate | 2 Hz | 2 Hz | Same |
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Image /page/6/Picture/0 description: The image shows a green shamrock inside of a white circle. A blurred purple arc surrounds the top and left side of the circle. The shamrock is a three-leaf clover, a symbol often associated with Ireland and Saint Patrick's Day. The overall design is simple and clean, with the green and purple colors providing a soft contrast.
Table 2 - Comparison table of the Subject device (HR Handpiece) and Predicate device (HR Module AFT Handpiece, SHR Module Handpieces)
| Device Feature | IPL System-
HR Handpiece | HarmonyXL-HR Module AFT
Handpiece | HarmonyXL-SHR Module
Handpieces | Comparison |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Wavelength | 640-950 nm | 650-950 nm | 780-950 nm | Note 1 |
| Indication for use | The IPL System - KDT750 is
intended for use in aesthetic
applications requiring
selective photothermolysis
(photocoagulation or
coagulation) of soft tissue in
the medical specialties of
general and plastic surgery,
and dermatology.
The removal of unwanted
hair to effect stable long-
term or permanent hair
reduction. For use on Fitzpatrick skin
types (I-V). * Permanent hair reduction is
defined as the long-term, stable
reduction in the number of hairs
regrowing when measured at 6. | Intended for use in aesthetic and
cosmetic applications requiring
selective photothermolysis
(photocoagulation or
coagulation) of soft tissue in the
medical specialties of general
and plastic surgery, and
dermatology The treatment of moderate
inflammatory acnevulgaris. The treatment of benign
pigmented epidermal
lesions, including
dyschromia,
hyperpigmentation,
melasma and
ephelides(freckles). The treatment of face and
body vascular and | Intended for use in aesthetic and
cosmetic applications requiring
selective photothermolysis
(photocoagulation or
coagulation) and hemostasis of
soft tissue in the medical
specialties of general and plastic
surgery, and dermatology The treatment of moderate
inflammatory acne
vulgaris. The treatment of benign
pigmented epidermal
lesions including
dyschromia,
hyperpigmentation,
melasma, and ephelides
(freckles). The treatment of cutaneous | Note 2 |
| | 9, and 12 months after the
completion of a treatment
regime. | • pigmentedlesions.
• The treatment of cutaneous
lesions, including scars and
striae.
• The treatment of benign
cutaneous vascular lesions,
including port wine stains,
hemangiomas, facial,
truncal and leg
telangiectasias, rosacea,
melasma, angiomas and
spider angiomas,
poikiloderma of Civatte,
leg veins and venous
malformations.
• The removal of unwanted
hair to effect stable long-
term or permanent hair
reduction.
• Use on all skin types
(Fitzpatrick I-VI) | • lesions including warts,
scars and striae.
• The treatment of benign
cutaneous vascular lesions
including port wine stains,
hemangiomas, facial,
truncal and leg
telangiectasias, rosacea,
erythema. of rosacea,
angiomas and spider
angiomas, poikilodermna
of Civatte, leg veins and
venous malformnations.
• The treatment of
pseudofolliculitis barbae
(PFB).
• The removal of unwanted
hair and to effect stable
long-term or permnanent
hair reduction.
• Use on all skin types
(Fitzpatrick I-VI),
including tanned skin. | |
| Light Source | Pulsed light with AFT and EDF | Pulsed light with AFT and EDF | Near Infrared pulsed light | Same |
| Timers/Pulse width | 1,3 and 30 seconds | 30, 40, 50 msec | 1, 3 and 30 seconds | Same |
| Energy Density
(Fluence) | 1-7 J/cm² | 5-25 J/cm² | 1-7 J/cm² | Note 4 |
| Spot Size | 15*50 mm (7.5 cm²) | 6.4 cm² | 3 cm² | Note 5 |
| Pulse Repetition
Rate | 3 Hz | 2/3 Hz | 3 Hz | Same |
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Image /page/7/Picture/0 description: The image shows a green shamrock with three leaves. A light purple arc surrounds the shamrock, adding a sense of motion or emphasis to the design. The overall impression is a simple, clean logo or emblem, possibly related to Irish culture or St. Patrick's Day.
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Image /page/8/Picture/0 description: The image shows a green shamrock with three leaves, which is a symbol often associated with Ireland and Saint Patrick's Day. The shamrock is encircled by a curved, light purple shape, possibly suggesting movement or a stylized frame. The background is plain white, which makes the green and purple colors stand out.
Difference Analysis:
Note 1 Wavelength
The wavelength range of proposed devices is very closed to predicate difference is considered to have no negative effect on effectiveness and safety, and the bench tests conducted on the proposed device substantial equivalence to the predicate device.
Note 1 Indications for Use
Though the Harmony's has more indications than the KDT750's, the intended use of subject device is covered by the predicate device, which forms the foundation of their comparison, which will not result in negative safety and effectiveness, this forms the foundation of Substantial Equivalence.
Note 3: Timers
The proposed device (K220214, SR Handpiece) has a similar timer range as the predicate device (K072564, SSR Handpiece). The slight difference in settings do not result in negative safety and effectiveness. The bench tests conducted on the proposed device support substantial equivalence to the predicate device
Note 4: Energy Density (Fluence)
The proposed device has an energy density that is similar to the differences do not result in negative safety and efficacy effects. The bench tests conducted on the proposed device support substantial equivalence to the predicate device.
Note 5: Spot Size
The proposed device has a larger spot size with the predicate device. However the differences in spot sizes are not considered to produce a negative effect on safety and safety. The bench tests conducted on the proposed device substantial equivalence to the predicate device.
The differences noted between IPL System - KDT750 and the predicate device, Alma Harmony™ Multi-Application Platform (K072564), do not present any new or different questions related to safety and effectiveness.
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Image /page/9/Picture/0 description: The image shows a green shamrock with three leaves. The shamrock is positioned in the center of the image and is surrounded by a light purple, curved shape that partially encircles it. The background is white, which makes the shamrock and the purple shape stand out.
7.0 Discussion of Tests Performed
7.1 Clinical Tests
Clinical testing was not performed for the subject device as part of the submission.
7.2 Non-Clinical Tests
The following performance data are provided in support of the substantial equivalence determination:
-
Electrical Safety and Electromagnetic Compatibility (EMC)
IEC60601-1:2005+CORR.1:2006+CORR.2:2007+A1:2012
Test for Medical Electrical equipment was performed for General Requirements for basic safety and essential performance;
IEC 60601-1-2:2014 Test for Medical Equipment for General Requirements for basic safety and essential performance: electromagnetic compatibility
IEC 60825-1:2007, Safety of laser products - Part 1: Equipment classification and requirements.
IEC 60601-2-57:2011, Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
A Biocompatibility
ISO 10993-5:2009 Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity.
ISO 10993-10:2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
The conclusion from the testing is the device is safe and effective for its intended use, and performs as well or better than the predicate devices.
8.0 Software
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".
9.0 Conclusion
The IPL System-KDT750 is as safe and effective as its predicate devices.
The IPL System-KDT750 has the same intended use and same technological characteristics and specifications as its predicate devices. Thus, the IPL System is substantially equivalent to its predicate devices.