(311 days)
The indications for use for the SILKPRO-S20S-TWC include: The Super Hair Removal (SHR) Mode are intended for temporary hair reduction. The indications for use for the SILKPRO-S20S-755A include: The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen. Use on all skin types (Fitzpatrick L-VI), including tanned skin.(HR. SHR Modes) The indications for use for the SILKPRO-S20S-810B include: The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term. stable reduction in the number of airs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen. Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, and SHR Modes)
The working principle of SILKPRO Titanium Diode Laser System is selective photothermal effect. It uses its unique long pulse width laser to penetrate the epidermis to the hair follicle. The energy of the laser is preferentially absorbed by the melanin in the hair, so that the hair follicle produces high heat. Thereby destroying the structure of the hair follicle, making the hair lose the ability to regenerate, and achieving the purpose of hair removal. The treatment head adopts a uniquely designed sapphire dynamic cooling device. SILKPRO Titanium Diode Laser System is a sophisticated high-tech laser equipment. The machine includes water cooling system. Water flows through the pipes in the handpiece to dissipate heat for the light source and the TEC water cooling block , which is used to cool the skin tissue during treatment.
The provided text is a 510(k) premarket notification for a medical device, specifically a laser system for hair removal. It aims to demonstrate that the new device, SILKPRO Titanium Diode Laser System, is substantially equivalent to a legally marketed predicate device, the Soprano Titanium.
However, the provided document does not contain information about acceptance criteria or a study that specifically proves the device meets acceptance criteria in the context of an AI/ML-driven medical device. The document is a traditional 510(k) summary, which focuses on demonstrating substantial equivalence based on technological characteristics, intended use, and safety/performance verification through non-clinical testing (e.g., electrical safety, software validation, biocompatibility).
The text does not mention:
- Any AI/ML components or algorithms in the device.
- Performance metrics like sensitivity, specificity, or AUC, which are common for AI/ML validation.
- Test sets, training sets, ground truth establishment, expert adjudication, or MRMC studies.
Therefore, I cannot populate the requested table or sections related to AI/ML device validation. The information in the prompt is specific to an AI/ML system's evaluation, which is not described in the provided FDA document.
To directly answer your request based on the provided text, the document does not present the type of information needed to fill out the table and study description you've requested because the device (SILKPRO Titanium Diode Laser System) is a traditional laser device, not an AI/ML device.
The document primarily focuses on demonstrating substantial equivalence by comparing the technical specifications and intended use of the proposed device to a predicate device. The "acceptance criteria" are implied by meeting the standards and demonstrating similar safety and performance characteristics to the predicate, as verified through non-clinical tests.
If this were an AI/ML device, the requested information would be crucial. Since it is not, the concept of "acceptance criteria" and "study proving it meets acceptance criteria" for an AI/ML system, as you've defined, is not applicable here.
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Image /page/0/Picture/0 description: The image shows 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 is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
July 30, 2023
Lotuxs Medtech (Suzhou) Co., Ltd. Na Wu Quality Manager Room301,303,304, Building6, Northwest Area of Nanopolis Suzhou,No.99 Jinjihu Avenue Suzhou Industrial Park, Suzhou, Jiangsu 215123 China
Re: K222862
Trade/Device Name: SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWC 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: June 30, 2023 Received: June 30, 2023
Dear Na Wu:
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.
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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) K222862
Device Name
SILKPRO Titanium Diode Laser System
Indications for Use (Describe)
The indications for use for the SILKPRO-S20S-TWC include:
The Super Hair Removal (SHR) Mode are intended for temporary hair reduction.
The indications for use for the SILKPRO-S20S-755A include:
The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen.
Use on all skin types (Fitzpatrick L-VI), including tanned skin.(HR. SHR Modes)
The indications for use for the SILKPRO-S20S-810B include:
The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term. stable reduction in the number of airs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen.
Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, and SHR Modes)
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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Section 5 - 510(k) Summary
K22862 Date of Summary Preparation: September 15, 2022 Date of Modification: July 29, 2023
1. Submitter's Identifications
Submitter's Name: Lotuxs Medtech (Suzhou) Co., Ltd. Address: Room301,303,304, Building6, Northwest Area of Nanopolis Suzhou, No.99 Jinjihu Avenue, Suzhou Industrial Park, Suzhou 215123, China Contact Person: Na Wu Contact Title: Quality Manager Contact Email Address: na.wu@lotuxs.com Telephone: +86-0512-62880553
2. Correspondent's Identifications
Correspondent's Name: Lotuxs Medtech (Suzhou) Co., Ltd. Address: Room301,303,304, Building6, Northwest Area of Nanopolis Suzhou, No.99 Jinjihu Avenue, Suzhou Industrial Park, Suzhou 215123, China ZIP Code: 215123 Contact Person: Na Wu Contact Title: Quality Manager Contact E-mail Address: na.wu@lotuxs.com Telephone: +86-0512-62880553
3. Name of the Device
Device Classification Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Product Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Trade Name: SILKPRO Titanium Diode Laser System Model: SILKPRO-S20S-TWC, SILKPRO-S20S-755A, SILKPRO-S20S-810B. Classification Panel: General & Plastic Surgery Product Code: GEX Regulation Number: 21 CFR 878.4810 Device Classification: Class II
4. The Predicate Devices
Primary Predicate device: K222064 Soprano Titanium
5. Device Description
The working principle of SILKPRO Titanium Diode Laser System is selective
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photothermal effect. It uses its unique long pulse width laser to penetrate the epidermis to the hair follicle. The energy of the laser is preferentially absorbed by the melanin in the hair, so that the hair follicle produces high heat. Thereby destroying the structure of the hair follicle, making the hair lose the ability to regenerate, and achieving the purpose of hair removal. The treatment head adopts a uniquely designed sapphire dynamic cooling device.
SILKPRO Titanium Diode Laser System is a sophisticated high-tech laser equipment. The machine includes water cooling system. Water flows through the pipes in the handpiece to dissipate heat for the light source and the TEC water cooling block , which is used to cool the skin tissue during treatment.
6. Intended Use of Device
The indications for use for the SILKPRO-S20S-TWC include:
The Super Hair Removal (SHR) Mode are intended for temporary hair reduction.
The indications for use for the SILKPRO-S20S-755A include:
The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen.
Use on all skin types (Fitzpatrick L-VI), including tanned skin.(HR. SHR Modes)
The indications for use for the SILKPRO-S20S-810B include:
The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term. stable reduction in the number of airs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen.
Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, and SHR Modes)
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7. Summary of Substantial Equivalence
Table 1
| Proposed device | Primary predicate device | Comparison | |
|---|---|---|---|
| 510k Number | K222862 | K222064 | -------- |
| Product Code | GEX | GEX, ILY | Same |
| Proprietary Name | SILKPRO Titanium Diode Laser System | Soprano Titanium | -------- |
| Model | SILKPRO-S20S-TWC,SILKPRO-S20S-755A,SILKPRO-S20S-810B, | / | -------- |
| Manufacturer | Lotuxs Medtech (Suzhou) Co., Ltd. | Alma Lasers Inc. | -------- |
| Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 | Same |
| Regulatory Class | Class II | Class II | Same |
| Controls | Footswitch or handpiece | Footswitch or handpiece | Same |
| Indications for use | The indications for use for theSILKPRO-S20S-TWC include:The super hair removal (SHR) Mode areintended for temporary hair reduction.The indications for use for theSILKPRO-S20S-755A include:The hair removal (HR) and super hairremoval (SHR) Mode are intended forpermanent reduction in hair regrowth | The Soprano Titanium diode laser module isintended for use in dermatology proceduresrequiring coagulation. The indications foruse for the Soprano Trio diode laser moduleinclude:The Super Hair Removal ( SHR ) Mode isintended for temporary hair reduction.The Soprano Trio diode laser module HRmode is intended for use in dermatology | Same |
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| defined as a long term, stable reduction inthe number of hairs re-growing whenmeasured at 6,9 and 12 months after thecompletion of a treatment regimen.Use on all skin types (Fitzpatrick L-VI),including tanned skin.(HR. SHR Modes)The indications for use for theSILKPRO-S20S-810B include:The hair removal (HR) and super hairremoval (SHR) Mode are intended forpermanent reduction in hair regrowthdefined as a long term. stable reduction inthe number of hairs re-growing whenmeasured at 6,9 and 12 months after thecompletion of a treatment regimen.Use on all skin types (Fitzpatrick I-VI),including tanned skin.(HR, and SHRModes) | procedures requiring coagulation indicationsfor use for the Soprano Trio diode laser HRmodule include : Benign vascular andvascular dependent lesions.810nm ApplicatorSoprano Titanium 810 nm applicatorintended use and indications for use:The indications for use for the 810nmModified Diode Laser Module 2 cm 2include:The Hair Removal ( HR ) and Super HairRemoval ( SHR ) Mode are intended forpermanent reduction in hair regrowthdefined as a long term , stable reduction inthe number of hairs re-growing whenmeasured at 6 , 9 and 12 months after thecompletion of a treatment regimenUse on all skin types ( Fitzpatrick I-VI ) ,including tanned skin . HR , and SHRModes.755nm ApplicatorSoprano Titanium 755 nm applicatorintended use and indications for use:The indications for use for the 755nm DiodeLaser Module include:The Hair Removal ( HR ) and Super Hair |
|---|---|
| ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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| Removal ( SHR ) Mode are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regimen Use on all skin types (Fitzpatrick I-VI), including tanned skin . HR, and SHR Modes. NIR Applicator: NIR Applicator intended use and indications for use: The Alma Lasers NIR Modules intended use is to emit energy in the near infrared ( NIR ) spectrum to provide topical heating. The indications for use for NIR Modules are: Elevating the tissue temperature for the temporary relief of minor muscle pain and joint pain and stiffness . The temporary relief of minor joint pain associated with arthritis The temporary increase in local circulation where applied , and The relaxation of muscles may also help muscle spasms , minor sprains and strains , and minor | |
|---|---|
| -- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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| muscular back pain. | |||
|---|---|---|---|
| Operating theory | The working principle of SILKPRO Titanium Diode Laser System is selective photothermal effect. It uses its unique long pulse width laser to penetrate the epidermis to the hair follicle. The energy of the laser is preferentially absorbed by the melanin in the hair, so that the hair follicle produces high heat. Thereby destroying the structure of the hair follicle, making the hair lose the ability to regenerate, and achieving the purpose of hair removal. The treatment head adopts a uniquely designed sapphire dynamic cooling device. | The Soprano trio Diode Laser Module is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI); The working principle of Soprano trio Diode Laser Module is selective photothermal effect. It uses its unique long pulse width laser to penetrate the epidermis to the hair follicle. The energy of the laser is preferentially absorbed by the melanin in the hair, so that the hair follicle produces high heat. Thereby destroying the structure of the hair follicle, making the hair lose the ability to regenerate, and achieving the purpose of hair removal. The treatment head adopts a uniquely designed sapphire dynamic cooling device. | Same |
| Laser Type | GaAlAs Diode Laser array | GaAlAs Diode Laser array | Same |
| Handpiecetipmaterial | Sapphire | Sapphire | Same |
| Wavelength | SILKPRO-S20S-TWC:755nm/810nm/1064nm Three in onecombination wavelength | 755nm/810nm/1064nm Three in onecombination wavelength | Same |
| SILKPRO-S20S-755A:755 nm | 755 nm | Same | |
| SILKPRO-S20S-810B:810 nm | 810 nm | Same | |
| SILKPRO-S20S-TWC: 10×40 mm² | Soprano Trio: 4cm² | Same | |
| Spot size | SILKPRO-S20S-755A: 12×12 mm² | 755nm Applicator: 1.5 cm² | SimilarThe spot size ofthe proposeddevice issimilar to thepredicatedevice, so thisdefinition doesnot affect thesafety andeffectiveness. |
| SILKPRO-S20S-810B: 10×20mm² | 810nm Applicator :2cm² | Same | |
| SILKPRO-S20S-TWC: Up to 200 ms | Soprano Trio: Up to 200 ms | Same | |
| Pulse Width (ms) | SILKPRO-S20S-755A : 3.3-200 ms | 755nm Applicator: 3.3-200 ms | Same |
| SILKPRO-S20S-810B: 3.3-200 ms | 810nm Applicator : 3.3-200 ms | Same | |
| Pulse RepetitionRate | SILKPRO-S20S-TWC:SHR: Up to 10 Hz | Soprano Trio:HR: Up to10 HzSHR: Up to10 Hz | Same |
| SILKPRO-S20S-755A: | 755nm Applicator: | Same | |
| HR: 0.5-3HzSHR: 5-10Hz | HR: 0.5-3 HzSHR: 5-10 Hz | ||
| SILKPRO-S20S-810B:HR: 0.5-3HzSHR: 5-10Hz | 810nm Applicator:HR: 0.5-3 HzSHR: 5-10 Hz | Same | |
| Energy Density(Fluence) | SILKPRO-S20S-TWCSHR: 2-8 J/cm² | Soprano Trio:HR:2- 120 J/ cm²SHR: 2-20 J/ cm² | Same |
| SILKPRO-S20S-755AHR: Up to 120J/ cm²SHR: Up to 20J/ cm² | 755nm Applicator:HR: Up to 120J/ cm²SHR: Up to 20J/ cm² | Same | |
| SILKPRO-S20S-810BHR: 2-120J/ cm²SHR: 2-20J/ cm² | 810nm Applicator:HR:2-120J/ cm²SHR:2-20J/ cm² | Same | |
| User Interface | LCD Color Touchscreen | LCD Color Touchscreen | Same |
| Laser classification | Class IV | Class IV | Same |
| Cooling system | TEC | TEC | Same |
| Software | Yes | Yes | Same |
| Delivery Devices(How supplied) | Non -Sterile. reusable. cleanable | Non -Sterile. reusable. cleanable | Same |
| Electromagneticcompatibility andelectrical safetycompliance | IEC 60601-1 | IEC 60601-1 | Same |
| IEC 60601-1-2 | IEC 60601-1-2 | ||
| IEC 60825-1 | IEC 60825-1 | ||
| IEC 60601-2-22 | IEC 60601-2-22 | ||
| Discussion forSubstantiallyEquivalent (SE) | The proposed device SILKPRO Titanium Diode Laser System series products has the same purpose as thepredicate device: product code, Regulation No., Regulatory Class , Controls, indications for use, Operatingtheory , Laser Type, Handpiece tipmaterial , wavelength, Spot size, Pulse Width (ms), Pulse Repetition Rate,Energy Density (Fluence) ,user interface, Laser classification, Cooling system , Software, delivery devicesand Electromagnetic compatibility and electrical safety compliance. These items can be controlled withinthe scope of application. These small differences between the proposed devices and predicate devices do notcause new safety and effectiveness problems. According to the non clinical test results, the proposed deviceis as safe, effective and has good performance as the predicate device.So the proposed device is Substantially Equivalent (SE) to the predicate device which is US legally marketdevice. |
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8. Non-Clinical Tests Submitted:
Software verification and validation was performed, and it was demonstrated that the software performs as intended according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. Testing confirmed that the power output meets specification. Electromagnetic compatibility and electrical safety testing was performed per standards ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-22 and IEC 60825-1. Results confirmed the device meets the standards. All patient contacting materials were assessed as per ISO 10993-1 and found to be biocompatible.
9. Conclusions drawn from clinical and non-clinical tests submitted:
Lotuxs believes that SILKPRO Titanium Diode Laser System series products is substantially equivalent to its predicate devices with same indications for use, similar technological characteristics. The non-clinical data for SILKPRO Titanium Diode Laser System series products supports the safety of the device and the biocompatibility, hardware and software verification and validation demonstrate that the SILKPRO Titanium Diode Laser System series products should perform as intended in the specified use conditions.
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§ 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.