(85 days)
Not Found
No
The document describes a laser hair removal system with different wavelengths and handpieces. There is no mention of AI or ML in the intended use, device description, or performance studies. The system's functionality appears to be based on pre-programmed laser parameters and automatic handpiece identification, not adaptive learning or data analysis.
Yes
The device is described as a "photothermal effect surgical laser device" that delivers a "high-power therapeutic laser beam" to destroy hair follicles, indicating a therapeutic intent beyond mere cosmetic alteration.
No
Explanation: The device is described as a "photothermal effect surgical laser device" intended for "permanent reduction in hair regrowth" or "temporary hair reduction" by destroying hair follicles. Its primary function is therapeutic (hair removal), not diagnostic (identifying a disease or condition).
No
The device description explicitly states it is comprised of a console, handpieces, and a water-loop cooling system, which are all hardware components. The software mentioned is for operating and monitoring the laser, not the primary medical device itself.
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 examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Function: The described device is a diode laser system that uses light energy to target and destroy hair follicles on the body. It is a therapeutic device applied directly to the patient.
- Intended Use: The intended use is for hair reduction, which is a cosmetic or therapeutic procedure performed on the patient's skin, not a diagnostic test performed on a sample.
- Device Description: The description focuses on the laser technology, handpieces, and cooling system, all of which are components of a device used for direct treatment.
- Performance Studies: The performance studies mentioned are related to the device's safety and functionality as a laser system (energy output, electrical safety, biocompatibility), not the accuracy of a diagnostic test.
Therefore, this device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Diode Laser System includes 2 types of handpieces with same 1.2 x 1.4 cm spot size:
Single-Wavelength Handpiece
810nm wavelength
The 810nm wavelength handpiece is 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 FHR Modes)
Trio-Wavelength Handpiece
The Trio-Wavelength Handpiece combines 3 wavelengths (755+810+1064 mm) into a single handpiece. It is intended for temporary hair reduction in Fast Hair Removal Mode (FHR).
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
Diode Laser System is a photothermal effect surgical laser device intended for prescription use and is comprised mainly of three components: console, handpieces and water-loop cooling system. There is plenty of melanin in hair follicles and hair shafts. Melanin scatters among hair bulbs and shaft structures (like medullary substance, cortex, and cuticula pili). The laser wavelengths that ST-803 Diode Laser System uses can be well absorbed by melanin, which causes a rapid increase in temperature, destroying surrounding hair follicles, and finally removing hair. The control panel is in the form of an LCD touch screen in front of device and displays for operating and monitoring the laser. The system can automatically identify different handpieces. The product includes 2 types of handpieces that are in the same spot size and 2 combinations of wavelengths.
The diode is exited to emit a high-power therapeutic laser beam intended to reduce unwanted body hair (e.g., armpit, leg, arm, back, chest and bikini line). It is intended to be used by a trained professional to emit a laser of wavelength around 810 nm or 755+810+1064 nm, delivered by a dedicated handpiece, to destroy hair follicles by heat.
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
The device is intended to be used by a trained professional.
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)
The Diode Laser System has been determined through engineering testing to verify laser energy output and electrical safety.
Electrical safety and electromagnetic compatibility: The test results demonstrated that the proposed device complies with the following standards: IEC 60601-1: 2005+corr.1:2006+Corr.2.2007+A1:2012, IEC 60601-1-2:2020, IEC 60825-1:2014, and IEC 60601-2-22:2019.
Software Verification and Validation Testing: 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." The software for this device was considered as a "moderate" level of concern since a failure of the software could result in minor injury to a patient or to a user of the device.
Sterilization and Shelf-Life: The proposed device is not provided sterile and does not need to be sterilized. The handpiece and the body are cleaned with a soft cloth moistened with ethanol of 70% strength or higher. The proposed device is reusable and does not have a restricted shelflife.
Biocompatibility: The handpiece sapphire tip may be contact with the intact skin of patients. According to FDA guidance document "Use of International Standard ISO 10993-1, " Biological evaluation of medical device - Part 1: Evaluation and testing within a risk management process "" three biological effects were determined in following three test: Cytotoxicity, Sensitization and Irritation.
- Cytotoxicity test: L-929 cell cultured in 96-well plates were treated with extract of test article (100%, 75%, 50%, and 5% in MEM medium) and then incubated at 37°C in cell incubator of 5% Diode for 24h. Viability % of the 100% extract of stainless steel and aluminum alloy is 83.2% and 87.9%. respectively, so the extract of test article passed test requirement and did not show potential cytotoxicity to mouse fibroblast L-929 cells.
- Skin sensitization test: Guinea Pig Maximization Test (GPMT) were performed for determination of the skin sensitizing potential of test article extraction. Under GPMT method, the results shows the test article did not cause delayed dermal contact sensitization in the guinea pig.
- Skin irritation test: The extraction solution of the test article (extraction in 0.9% sodium chloride injection and sesame oil) and control solution were treated on the backs of fur clipped rabbits. The appearance of each application site was recorded and scored after 1 hour, 24 hours and 72 hours treatment. The score of skin reaction of test extraction at different time point were 0 as negative control group and showed no potential skin irritation risk.
Three biological effects, cytotoxicity, sensitization and irritation testing, were performed and test results did not identify any biological response or risk. The Diode Laser System meets the ISO 10993-1 standard requirements for biocompatibility and no further characterization testing is required.
Bench testing: Bench testing was conducted to validate that the energy output parameters of the subject device are similar to those of the predicate device.
Key results: The non-clinical data and performance testing reports in this submission demonstrate that Diode Laser System meets the expected performance requirements. Any difference between the subject and predicate device do not raise new issues of safety or effectiveness. Based on above analysis, the Diode Laser System is as safe, as effective, and performs as well as the cited predicate device.
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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.
May 26, 2023
Smedtrum Medical Technology Co., Ltd. Crimson Wu Senior Regulatory Engineer 1F., No. 8, Ln. 97, Wugong Rd., New Taipei City, Xinzhuang Dist. 248016 Taiwan
Re: K230580
Trade/Device Name: Diode Laser System 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: April 28, 2023 Received: May 1, 2023
Dear Crimson 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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
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) K230580
Device Name Diode Laser System
Indications for Use (Describe)
The Diode Laser System includes 2 types of handpieces with same 1.2 x 1.4 cm spot size:
Single-Wavelength Handpiece
810nm wavelength
The 810nm wavelength handpiece is 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 FHR Modes)
Trio-Wavelength Handpiece
The Trio-Wavelength Handpiece combines 3 wavelengths (755+810+1064 mm) into a single handpiece. It is intended for temporary hair reduction in Fast Hair Removal Mode (FHR).
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image contains a logo for a medical technology company. The logo features a stylized geometric shape in shades of blue, resembling an abstract letter 'S'. To the right of the shape is the company name, "Smedtrum MEDICAL TECHNOLOGY CO.", with "Smedtrum" in a larger, light blue font and the rest of the name in a smaller, gray font. Above the company name is the Chinese translation of the company name.
Smedtrum Medical Technology Co., Ltd. 1F., No. 8, Ln. 97, Wugong Rd., Xinzhuang Dist., New Taipei City 248016 , Taiwan TEL:+886 (02) 2298 9578 FAX:+886 (02) 2298 9426
Section 5 : 510(k) Summary Diode Laser System
I. SUBMITTER
Smedtrum Medical Technology Co., Ltd. 1F., No. 8, Ln. 97, Wugong Rd., Xinzhuang Dist., New Taipei City 248016, Taiwan (R.O.C.) Contact Person Crimson Wu
Position: Senior Regulatory Engineer Tel: +886-2-2298-9578, Ext. 301 Fax: +886-2-2298-9426 E-mail: crimsonwu@smedtrum.com Date of preparation: May 9th, 2023
II. DEVICE
| Trade Name: | Diode Laser System |
|---|---|
| Common or Usual Name: | Surgical Laser Device |
| Product code: | GEX |
| Classification Name: | Laser surgical instrument for use in general and plastic |
| surgery and in dermatology. |
21 C.F.R. § 878.4810, Device Class II
PREDICATE DEVICE III.
| Manufacturer | Alma Lasers Inc. |
|---|---|
| Trade Name: | The Alma Soprano Titanium |
| Common or Usual Name: | Surgical Laser Device |
| Classification Name: | Laser surgical instrument for use in general and plastic |
| surgery and in dermatology. | |
| 21 C.F.R. § 878.4810, Device Class II | |
| Premarket Notification: | K222064 Oct 12th, 2022 |
IV. DEVICE DESCRIPTION
Diode Laser System is a photothermal effect surgical laser device intended for prescription use and is comprised mainly of three components: console, handpieces and water-loop cooling system. There is plenty of melanin in hair follicles and hair shafts. Melanin scatters among hair bulbs and shaft structures (like medullary substance, cortex, and cuticula pili). The laser wavelengths that ST-803 Diode Laser
4
Image /page/4/Picture/1 description: The image contains a logo for Smedtrum Medical Technology CO., LTD. The logo features a stylized blue and gray geometric shape on the left. To the right of the shape is the text "Smedtrum" in a combination of gray and blue, with the first half in gray and the second half in blue. Above the company name is the company's name in Chinese characters, and below the name is the text "MEDICAL TECHNOLOGY CO., LTD." in gray.
Smedtrum Medical Technology Co., Ltd. 1F., No. 8, Ln. 97, Wugong Rd., Xinzhuang Dist., New Taipei City 248016 , Taiwan TEL:+886 (02) 2298 9578 FAX:+886 (02) 2298 9426
System uses can be well absorbed by melanin, which causes a rapid increase in temperature, destroying surrounding hair follicles, and finally removing hair. The control panel is in the form of an LCD touch screen in front of device and displays for operating and monitoring the laser. The system can automatically identify different handpieces. The product includes 2 types of handpieces that are in the same spot size and 2 combinations of wavelengths.
The diode is exited to emit a high-power therapeutic laser beam intended to reduce unwanted body hair (e.g., armpit, leg, arm, back, chest and bikini line). It is intended to be used by a trained professional to emit a laser of wavelength around 810 nm or 755+810+1064 nm, delivered by a dedicated handpiece, to destroy hair follicles by heat.
INDICATIONS FOR USE V.
The Diode Laser System includes 2 types of handpieces with same 1.2 x 1.4 cm spot size:
Single-Wavelength Handpiece
810 nm wavelength
The 810 nm wavelength handpiece is 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 FHR Modes)
Trio-Wavelength Handpiece
The Trio-Wavelength Handpiece combines 3 wavelengths (755+810+1064 nm) into a single handpiece. It is intended for temporary hair reduction in Fast Hair Removal Mode (FHR).
COMPARISON OF TECHNOLOGICAL CHARATERISTICS WITH THE VI.
PREDICATE DEVICE
| Feature | Proposed device | Predicate device
(K222064) |
|--------------|--------------------|-------------------------------|
| Device Name | Diode Laser System | The Alma Soprano Titanium |
| Product Code | GEX | GEX |
5
Sm
巨興醫學科技股份有限公司
um
Smedtrum Medical Technology Co., Ltd. 1F., No. 8, Ln. 97, Wugong Rd., Xinzhuang Dist., New Taipei City 248016 , Taiwan
TEL : +886 (02) 2298 9578 FAX : +886 (02) 2298 9426
| Feature | Proposed device | Predicate device
(K222064) |
|----------------|-----------------|-------------------------------|
| Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 |
| Device Class | Class II | Class II |
6
S
巨興醫學科技股份有限公司
um
Smedtrum Medical Technology Co., Ltd. 1F., No. 8, Ln. 97, Wugong Rd., Xinzhuang Dist., New Taipei City 248016 , Taiwan
TEL : +886 (02) 2298 9578 FAX : +886 (02) 2298 9426
| Indication for Use | ||
|---|---|---|
| The Diode Laser System | ||
| includes 2 types of | ||
| handpieces with same 1.2 | ||
| x 1.4 cm spot size: |
Single-Wavelength
Handpiece
810nm wavelength
The 810nm wavelength
handpiece is 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 FHR
Modes) | 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 Titanium diode
laser module HR mode is
intended for use in dermatology
procedures requiring
coagulation. The indications for
use for the Soprano Trio diode
laser module include: Benign
vascular and vascular dependent
lesions. |
| | Trio-Wavelength
Handpiece
The Trio-Wavelength
Handpiece combines 3
wavelengths
(755+810+1064 nm) into
a single handpiece. It is
intended for temporary
hair reduction in Fast
Hair Removal Mode
(FHR). | 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 cm² 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 |
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Image /page/7/Picture/1 description: The image shows a logo for a medical company. The logo consists of two teal-colored, overlapping triangles that form an abstract shape resembling the letter 'S'. To the right of the shape, the word "Smart" is written in a light gray sans-serif font. Below "Smart", the word "MEDICAL" is written in a smaller font size. To the right of the word "Smart", there are some Chinese characters.
Smedtrum Medical Technology Co., Ltd. 1F., No. 8, Ln. 97, Wugong Rd., Xinzhuang Dist., New Taipei City 248016 , Taiwan TEL:+886 (02) 2298 9578 FAX:+886 (02) 2298 9426
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 Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a 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. ● Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, 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.
8
| Feature | Proposed device | Predicate device (K222064) |
|---|---|---|
| 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 muscular back pain. | ||
| Laser Type | GaAlAs Diode Laser array | GaAlAs Diode Laser array |
| Laser Classification | Class IV | Class IV |
| Laser Wavelength | 810 nm and Trio-wavelength | |
| 755+810+1064 nm | 810 nm, 755 nm, NIR and Trio-wavelength 755+810+1064 nm | |
| Laser Delivery System | Handpiece | Handpiece |
| Beam Delivery Handpiece | 810 nm and Trio-wavelength | |
| 755+810+1064 nm | 810 nm and Trio-wavelength | |
| 755+810+1064 nm | ||
| Laser firing Controls | LCD color Touchscreen | LCD color Touchscreen |
| Footswitch | ||
| Laser Module Power | 1600W | 600W/800W/1000W/1200W/ |
| 1600W | ||
| Fluence | Single- | HR |
| HR | FHR | |
| FHR | SHR |
9
| J/cm2
J/cm2
2 cm2
J/cm2
J/cm2
755 nm
Up to 120
J/cm2
J/cm2
Trio-
212020
2
wavelength
Trio-
J/cm2
J/cm2
4 cm2
Wavelen
183 Hz
gth
NIR
Min:10W
J/cm2
Max:>25J
Frequency
0.5
1, 2, 3, 5, 8,10 Hz (6
810 nm
2 cm2
adjustable levels)
755 nm
0.53 Hz200 ms
Trio-
Up to 10
wavelength
Hz
Hz
4 cm2
NIR
CW
Pulse width
810 nm: 3.3
5200 ms200 ms
(Max)
755 nm: 3.3
Trio-wavelength: Up to 200 ms
Spot Size
Both handpieces: 1.2
810nm: 1 cm2 and 2 cm2,
cm×1.4 cm
755nm: 1.5 cm2,
Trio-wavelength: 2 cm2 and 4 cm2
NIR: 18 cm2 and 6.4 cm2
110-240VAC, 22-10A,
230 VAC, 16A, 50/60 Hz
Power Input
50/60 Hz
Cooling
water + air + TEC
water + air + TEC | Feature | MEDICAL TECHNOLOGY CO.,LT
Proposed device | | | Predicate device
(K222064) | | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|----------------------------------------------|--|--|-------------------------------|--|----------|--|
| | | | | | | | | |
| | | | | | | | Up to 20 | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | 510 Hz | |10 Hz | |
| | | | | | | | 5
| | | | | | | | Up to 10 | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| 84 Kg
55 Kg | Appearance | 119.5 cm x 58 cm x 61 cm, | | | 120 cm x 39 cm x 38 cm, | | | |
VII. PERFORMANCE DATA
The Diode Laser System has been determined through engineering testing to verify laser energy output and electrical safety.
Electrical safety and electromagnetic compatibility
The test results demonstrated that the proposed device complies with the following standards:
IEC 60601-1: 2005+corr.1:2006+Corr.2.2007+A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
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Image /page/10/Picture/1 description: The image contains a logo for a company called "Smedtrum Medical Technology Co., Ltd." The logo consists of a geometric shape on the left, resembling an abstract letter "S" in shades of teal. To the right of the shape is the company name in both Chinese and English. The Chinese characters are at the top, and the English name "Smedtrum" is in a larger font size, with "MEDICAL TECHNOLOGY CO., LTD." below it in smaller letters.
IEC 60601-1-2:2020 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance-Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60825-1:2014 Safety of Laser products-Part 1: Equipment classification and requirements
IEC 60601-2-22:2019 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
Software Verification and Validation Testing
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." The software for this device was considered as a "moderate" level of concern since a failure of the software could result in minor injury to a patient or to a user of the device.
Sterilization and Shelf-Life
The proposed device is not provided sterile and does not need to be sterilized. The handpiece and the body are cleaned with a soft cloth moistened with ethanol of 70% strength or higher. The proposed device is reusable and does not have a restricted shelflife.
Biocompatibility
The handpiece sapphire tip may be contact with the intact skin of patients. According to FDA guidance document "Use of International Standard ISO 10993-1, " Biological evaluation of medical device - Part 1: Evaluation and testing within a risk management process "" three biological effects were determined in following three test: Cytotoxicity, Sensitization and Irritation.
In Cytotoxicity test, L-929 cell cultured in 96-well plates were treated with extract of test article (100%, 75%, 50%, and 5% in MEM medium) and then incubated at 37°C in cell incubator of 5% Diode for 24h. Viability % of the 100% extract of stainless steel and aluminum alloy is 83.2% and 87.9%. respectively, so the extract of test article passed test requirement and did not show potential cytotoxicity to mouse fibroblast L-929 cells.
In Skin sensitization test. Guinea Pig Maximization Test (GPMT) were performed for determination of the skin sensitizing potential of test article extraction. Under
11
巨興醫學科技股份有限公司
Smedtrum
MEDICAL TECHNOLOGY CO.,LTD.
GPMT method, the results shows the test article did not cause delayed dermal contact sensitization in the guinea pig.
In Skin irritation test, the extraction solution of the test article (extraction in 0.9% sodium chloride injection and sesame oil) and control solution were treated on the backs of fur clipped rabbits. The appearance of each application site was recorded and scored after 1 hour, 24 hours and 72 hours treatment. The score of skin reaction of test extraction at different time point were 0 as negative control group and showed no potential skin irritation risk.
Three biological effects, cytotoxicity, sensitization and irritation testing, were performed and test results did not identify any biological response or risk. The Diode Laser System meets the ISO 10993-1 standard requirements for biocompatibility and no further characterization testing is required.
Bench testing
Bench testing was conducted to validate that the energy output parameters of the subject device are similar to those of the predicate device.
VIII. CONCLUSION
The Diode Laser System has the same intended use, similar indications for use, the same technological characteristics, the same energy used, and the same operating principles as its predicates. The non-clinical data and performance testing reports in this submission demonstrate that Diode Laser System meets the expected performance requirements. Any difference between the subject and predicate device do not raise new issues of safety or effectiveness. Based on above analysis, the Diode Laser System is as safe, as effective, and performs as well as the cited predicate device.