(311 days)
Not Found
No
The document describes a laser hair removal system based on selective photothermal effect and cooling mechanisms. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is described as a "hair removal" device intended for "permanent reduction in hair regrowth" or "temporary hair reduction," which are cosmetic rather than therapeutic indications.
No
This device is intended for hair reduction and removal, not for diagnosing medical conditions. It operates by destroying hair follicles using a laser based on selective photothermal effects.
No
The device description explicitly details hardware components such as a laser system, treatment head with sapphire cooling, and a water cooling system, indicating it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The SILKPRO Titanium Diode Laser System is described as a laser equipment that uses selective photothermal effect to target hair follicles for hair removal. It works by applying laser energy to the skin.
- Intended Use: The intended use is for temporary or permanent hair reduction. This is a physical treatment applied to the body, not a diagnostic test performed on a sample.
The device's function and intended use clearly fall outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
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 I-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)
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
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.
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
Not Found
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)
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.
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.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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). 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.
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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.
3
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
4
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)
5
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 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 | The Soprano Titanium diode laser module is | ||
| intended for use in dermatology procedures | |||
| requiring coagulation. The indications for | |||
| use for the Soprano Trio diode laser module | |||
| include: | |||
| The Super Hair Removal ( SHR ) Mode is | |||
| intended for temporary hair reduction. | |||
| The Soprano Trio diode laser module HR | |||
| mode is intended for use in dermatology | Same |
6
| 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 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) | procedures requiring coagulation indications
for use for the Soprano Trio diode laser HR
module include : Benign vascular and
vascular dependent lesions.
810nm Applicator
Soprano Titanium 810 nm applicator
intended use and indications for use:
The indications for use for the 810nm
Modified Diode Laser Module 2 cm 2
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 I-VI ) ,
including tanned skin . HR , and SHR
Modes.
755nm Applicator
Soprano Titanium 755 nm applicator
intended use and indications for use:
The indications for use for the 755nm Diode
Laser Module include:
The Hair Removal ( HR ) and Super Hair |
| ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
7
| 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 | |
|---|---|
| -- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
8
| 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 |
| Handpiece | |||
| tipmaterial | Sapphire | Sapphire | Same |
| Wavelength | SILKPRO-S20S-TWC: | ||
| 755nm/810nm/1064nm Three in one | |||
| combination wavelength | 755nm/810nm/1064nm Three in one | ||
| combination 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 | Similar |
| The spot size of | |||
| the proposed | |||
| device is | |||
| similar to the | |||
| predicate | |||
| device, so this | |||
| definition does | |||
| not affect the | |||
| safety and | |||
| effectiveness. | |||
| 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 Repetition | |||
| Rate | SILKPRO-S20S-TWC: | ||
| SHR: Up to 10 Hz | Soprano Trio: | ||
| HR: Up to10 Hz | |||
| SHR: Up to10 Hz | Same | ||
| SILKPRO-S20S-755A: | 755nm Applicator: | Same | |
| HR: 0.5-3Hz | |||
| SHR: 5-10Hz | HR: 0.5-3 Hz | ||
| SHR: 5-10 Hz | |||
| SILKPRO-S20S-810B: | |||
| HR: 0.5-3Hz | |||
| SHR: 5-10Hz | 810nm Applicator: | ||
| HR: 0.5-3 Hz | |||
| SHR: 5-10 Hz | Same | ||
| Energy Density | |||
| (Fluence) | SILKPRO-S20S-TWC | ||
| SHR: 2-8 J/cm² | Soprano Trio: | ||
| HR:2- 120 J/ cm² | |||
| SHR: 2-20 J/ cm² | Same | ||
| SILKPRO-S20S-755A | |||
| HR: Up to 120J/ cm² | |||
| SHR: Up to 20J/ cm² | 755nm Applicator: | ||
| HR: Up to 120J/ cm² | |||
| SHR: Up to 20J/ cm² | Same | ||
| SILKPRO-S20S-810B | |||
| HR: 2-120J/ cm² | |||
| SHR: 2-20J/ cm² | 810nm Applicator: | ||
| HR:2-120J/ cm² | |||
| SHR: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 |
| Electromagnetic | |||
| compatibility and | |||
| electrical safety | |||
| compliance | 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 for | |||
| Substantially | |||
| Equivalent (SE) | The proposed device SILKPRO Titanium Diode Laser System series products has the same purpose as the | ||
| predicate device: product code, Regulation No., Regulatory Class , Controls, indications for use, Operating | |||
| theory , Laser Type, Handpiece tipmaterial , wavelength, Spot size, Pulse Width (ms), Pulse Repetition Rate, | |||
| Energy Density (Fluence) ,user interface, Laser classification, Cooling system , Software, delivery devices | |||
| and Electromagnetic compatibility and electrical safety compliance. These items can be controlled within | |||
| the scope of application. These small differences between the proposed devices and predicate devices do not | |||
| cause new safety and effectiveness problems. According to the non clinical test results, the proposed device | |||
| is 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 market | |||
| device. |
9
10
11
12
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.
--- End of this section ---