(139 days)
Not Found
No
The device description and performance studies focus on the laser technology and its physical components, with no mention of AI or ML.
Yes
The "Intended Use / Indications for Use" section lists numerous applications for treating diseases, injuries, and conditions (e.g., "removal of diseased, inflamed and necrosed soft tissue," "treatment of aphthous ulcers," "incisions and draining of abscesses"), which aligns with the definition of a therapeutic device.
No
The device description and intended use outline various surgical and therapeutic procedures (e.g., incision, excision, hemostasis, removal of tissues, treatment of ulcers), but none of these functions are for the purpose of diagnosing a medical condition.
No
The device description explicitly states it is composed of a "laser host" and "optic fiber tip," which are hardware components.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly indicate that this device is a laser used for surgical procedures directly on soft tissue within and outside the mouth. It does not involve the analysis of biological samples like blood, urine, or tissue biopsies in vitro (outside the body).
- The device description focuses on the laser technology and its application to tissue. It describes how the laser is generated and delivered to the treatment site, which is consistent with a surgical device, not a diagnostic one.
- The performance studies mentioned are related to safety and effectiveness standards for medical devices (IEC standards), not diagnostic performance metrics. There are no mentions of sensitivity, specificity, or other metrics typically associated with diagnostic tests.
Therefore, this device is a surgical laser intended for therapeutic procedures, not an IVD.
N/A
Intended Use / Indications for Use
Intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue; marginal and interdental gingival and epithelial lining of free gingiva; frenotomy; biopsy; operculectomy; Implant recovery; gingivectomy; gingival troughing; crown lengthening; hemostasis of donor site; removal of granulation tissue; laser assisted flap surgery; debridement of deseased epithelial lining ; incisions and draining of abscesses; tissue retraction for impressions; papillectomy; vestibuloplasty; excision of lesions ; exposure of unerupted/ partially erupted teeth; removal of hyperplastic tissues; treatment of aphthous ulcers; leukoplakia; Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket; Sulcular debridement (removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth inability); pulpotomy; pulpotomy as adjunct to root canal therapy; Fibroma removal; Gingival incision; Treatment of canker sores; herpetic ulcers of the oral mucosa: Laser soft tissue curettage: Reduction of gingival hypertrophy:.
Product codes (comma separated list FDA assigned to the subject device)
NVK, GEX
Device Description
Principle: The semiconductor laser diode is excited by the generation power supply to generate the laser, which is effectively transmitted to the treatment site through the optical fiber tip.
Intended operator: Dental surgeon.
Component part: It is composed of laser host (including internal power system, laser drive system, optical path system, LCD screen, emergency stop button, laser) and optic fiber tip.
Sterile: The device mainframe not supplied sterile and do not require sterilization prior to use. The consumable component (Fiber optic tip) not supplied sterile but require sterilization prior to use.
Sterilization condition: 121℃ (250°F), 30min
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intra- and extra-oral
Indicated Patient Age Range
For use in all patients
Intended User / Care Setting
Dental surgeon; Hospital, clinic, and medical office setting
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 Test:
Clinical testing was not performed for SOGALaser (Model: ILaser I) as part of the submission.
Non-Clinical Tests:
The subject device was tested/analyzed according to the following standards in order to ensure its effectiveness and safety:
Electrical Safety: IEC 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
Electromagnetic Compatibility: IEC 60601-1-2 Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance – Collateral Standard: Electromagnetic Compatibility - Requirements And Tests
Performance Safety and Effectiveness: IEC 60825-1 Safety of laser products - Part 1: Equipment classification, and requirements
Performance Safety and Effectiveness: IEC 60601-2-22 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
Key Results: "The safety and essential effectiveness of the subject device have been evaluated according to the FDA recognized standards."
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 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".
May 10, 2022
Shenzhen Soga Technology Co., Ltd. Tse Adrian Quality Manager D906, Yinxing Technology Building No. 1301, Sightseeing Road Xinlan Community, Guanlan Street, Longhua District Shenzhen, Guangdong 518110 CHINA
Re: K214008
Trade/Device Name: Dental diode laser 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: NVK, GEX Dated: March 11, 2022 Received: March 11, 2022
Dear Tse Adrian:
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.
Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K214008
Device Name Dental Diode Laser
Indications for Use (Describe)
Intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue; marginal and interdental gingival and epithelial lining of free gingiva; frenotomy; biopsy; operculectomy; Implant recovery; gingivectomy; gingival troughing; crown lengthening; hemostasis of donor site; removal of granulation tissue; laser assisted flap surgery; debridement of deseased epithelial lining ; incisions and draining of abscesses; tissue retraction for impressions; papillectomy; vestibuloplasty; excision of lesions ; exposure of unerupted/ partially erupted teeth; removal of hyperplastic tissues; treatment of aphthous ulcers; leukoplakia; Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket; Sulcular debridement (removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth inability); pulpotomy; pulpotomy as adjunct to root canal therapy; Fibroma removal; Gingival incision; Treatment of canker sores; herpetic ulcers of the oral mucosa: Laser soft tissue curettage: Reduction of gingival hypertrophy:.
| 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/1 description: The image shows the logo for SOGA. The logo is in a dark gray color, with the letter A having a green triangle in the middle. Below the logo is the company name in Chinese.
005_510(k) Summary
5.1 Submitter Information
- Company: Shenzhen Soga technology Co., Ltd.
- Address: D906, Yinxing Technology Building No. 1301, Sightseeing Road, Xinlan Community, Guanlan Street, Longhua District, Shenzhen, Guangdong, China.
- Phone: +086-15915873605
- Contact: Tse Adrian, Quality Manager
- Mail box: 15915873605@Soga12.com ●
- Website: www.soga12.com
5.2 Device Information
- Trade/Device Name: Dental diode laser ●
- Model: ILaser I
- Common Name: Dental diode laser
- Classification regulation: Regulation number: 21 CFR 878.4810 Requlation Description: Manual surgical instrument for general use. Regulation Medical Specialty: General & Plastic Surgery
- Review Panel: General & Plastic Surgery
- Product Code: Primary product code: NVK; Secondary product code: GEX ●
- Regulation Number: 21 CFR 878.4810 ●
- Device Class: Class II
5.3 Predicate Device Information
Predicate Device: SIROLaser Advance (Model: FonaLaser)
Manufacturer: Sirona Dental Systems GmbH
510(k) number: K103753
Indication of use:
Intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue; marginal and interdental
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Image /page/4/Picture/1 description: The image shows the logo for SOGA. The logo is in a dark gray color, with the letter A in green. Below the logo is the company name in Chinese characters.
gingival and epithelial lining of free gingiva; frenectomy; frenotomy; biopsy; operculectomy; Implant recovery; gingivectomy; gingivoplasty; gingival troughing; crown lengthening; hemostasis of donor site; removal of granulation tissue; laser assisted flap surgery; debridement of deseased epithelial lining ; incisions and draining of abscesses; tissue retraction for impressions; papillectomy; vestibuloplasty; excision of lesions ; exposure of unerupted/partially erupted teeth; removal of hyperplastic tissues; treatment of aphthous ulcers; leukoplakia; Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket; Sulcular debridement (removal of diseased, infected, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth inability); pulpotomy; pulpotomy as adjunct to root canal therapy; Fibroma removal; Gingival incision and excision; Treatment of canker sores; herpetic ulcers of the oral mucosa; Laser soft tissue curettage; Reduction of gingival hypertrophy;.
5.4 Device Description
Principle: The semiconductor laser diode is excited by the generation power supply to generate the laser, which is effectively transmitted to the treatment site through the optical fiber tip.
Intended operator: Dental surgeon.
Component part: It is composed of laser host (including internal power system, laser drive system, optical path system, LCD screen, emergency stop button, laser) and optic fiber tip.
Sterile: The device mainframe not supplied sterile and do not require sterilization prior to use. The consumable component (Fiber optic tip) not supplied sterile but require sterilization prior to use.
Sterilization condition: 121℃ (250°F), 30min
5.5 Indications for Use
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Image /page/5/Picture/1 description: The image shows the logo for SOGA. The logo is in a dark gray color, with the letter A having a green triangle in the middle. Below the logo is the company name in Chinese, which is 索感科技.
Intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue; marginal and interdental gingival and epithelial lining of free gingiva; frenectomy; frenotomy; biopsy; operculectomy; Implant recovery; gingivectomy; gingivoplasty; gingival troughing; crown lengthening; hemostasis of donor site; removal of granulation tissue; laser assisted flap surgery; debridement of deseased epithelial lining ; incisions and draining of abscesses; tissue retraction for impressions; papillectomy; vestibuloplasty; excision of lesions ; exposure of unerupted/partially erupted teeth; removal of hyperplastic tissues; treatment of aphthous ulcers; leukoplakia; Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket; Sulcular debridement (removal of diseased, infected, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth inability); pulpotomy; pulpotomy as adjunct to root canal therapy; Fibroma removal; Gingival incision and excision; Treatment of canker sores; herpetic ulcers of the oral mucosa; Laser soft tissue curettage; Reduction of gingival hypertrophy;.
| Comparison
Items | Subject Device:
SOGALaser
(Model: ILaser I) | Predicate Device:
SIROLaser Advance
Model: FONALaser
(K103753) |
|-------------------------------|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| Classification & Intended Use | | |
| Classification | GEX, NVK
Class II
21 CFR 878.4810 | GEX
Class II
21 CFR 878.4810 |
| Intended use | Intra- and extra-oral
surgery including incision,
excision, hemostasis, | Intra- and extra-oral
surgery including incision,
excision, hemostasis, |
5.6 Comparison of Technological Characteristics with the Predicate Device
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Image /page/6/Picture/0 description: The image shows the text "Shenzhen Soga technology Co. Ltd." in a clear, sans-serif font. The text is horizontally aligned and appears to be the name of a company. The background is plain white, providing a clean and professional look to the text.
Image /page/6/Picture/1 description: The image shows the logo for SOGA, a technology company. The logo is in a dark gray color, with the letter 'A' in the logo having a green triangle in the middle. Below the logo, there are Chinese characters, and a black line is present at the bottom of the image.
coagulation and vaporization of soft tissue; marginal and interdental gingival and epithelial lining of free gingiva; frenectomy; frenotomy; biopsy; operculectomy; Implant recovery; gingivectomy; gingivoplasty; gingival troughing; crown lengthening; hemostasis of donor site; removal of granulation tissue; laser assisted flap surgery; debridement of deseased epithelial lining ; incisions and draining of abscesses; tissue retraction for impressions; papillectomy; vestibuloplasty; excision of lesions ; exposure of unerupted/partially erupted teeth; removal of hyperplastic tissues; treatment of aphthous ulcers; leukoplakia; Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket; Sulcular debridement (removal of diseased,
coagulation and vaporization of soft tissue; marginal and interdental gingival and epithelial lining of free gingiva; frenectomy; frenotomy; biopsy; operculectomy; Implant recovery; gingivectomy; gingivoplasty; gingival troughing; crown lengthening; hemostasis of donor site; removal of granulation tissue; laser assisted flap surgery; debridement of deseased epithelial lining ; incisions and draining of abscesses; tissue retraction for impressions; papillectomy; vestibuloplasty; excision of lesions ; exposure of unerupted/partially erupted teeth; removal of hyperplastic tissues; treatment of aphthous ulcers; leukoplakia; Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket; Sulcular debridement (removal of
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Image /page/7/Picture/0 description: The image shows the text "Shenzhen Soga technology Co. Ltd." in bold, black font. The text appears to be a company name. The background is plain white, providing a clear contrast for the text to stand out. There is a black line underneath the text.
Image /page/7/Picture/1 description: The image shows the logo for SOGA. The logo is in a dark gray color, with the letters "SOGA" in a stylized font. Below the letters is the company name in Chinese characters, which translates to "Suo Gan Technology". The "A" in SOGA has a green triangle in the middle.
| infected, inflamed and | diseased, infected, | |
|---|---|---|
| necrosed soft tissue in the | ||
| periodontal pocket to | ||
| improve clinical indices | ||
| including gingival index, | ||
| gingival bleeding index, | ||
| probe depth, attachment | ||
| loss and tooth inability); | ||
| pulpotomy; pulpotomy as | ||
| adjunct to root canal | ||
| therapy; Fibroma removal; | ||
| Gingival incision and | ||
| excision; Treatment of | ||
| canker sores; herpetic | ||
| ulcers of the oral mucosa; | ||
| Laser soft tissue curettage; | ||
| Reduction of gingival | ||
| hypertrophy;. | inflamed and necrosed | |
| soft tissue in the | ||
| periodontal pocket to | ||
| improve clinical indices | ||
| including gingival index, | ||
| gingival bleeding index, | ||
| probe depth, attachment | ||
| loss and tooth inability); | ||
| pulpotomy; pulpotomy as | ||
| adjunct to root canal | ||
| therapy; Fibroma removal; | ||
| Gingival incision and | ||
| excision; Treatment of | ||
| canker sores; herpetic | ||
| ulcers of the oral mucosa; | ||
| Laser soft tissue | ||
| curettage; Reduction of | ||
| gingival hypertrophy;. | ||
| Patient Population | For use in all patients | For use in all patients |
| Environment of | ||
| Use | For Dental surgeon | Prescription Use - For |
| professional | ||
| Patient Population | No restriction on the | |
| applicable population | All Population | |
| Comparison | ||
| Statement | The subject device enjoys the same classification and | |
| intended use with the predicate device. | ||
| Technological Characteristics | ||
| Principle / Method | ||
| of Operation | The semiconductor laser | |
| diode is excited by the | ||
| generation power supply to | ||
| generate the laser, which is | ||
| effectively transmitted to | It is generated by a laser | |
| diode in the control unit | ||
| and is guided through a | ||
| quartz fiber to the | ||
| treatment area. The laser | ||
| the treatment site through | ||
| the fiber optic tip. | radiation is absorbed by | |
| the tissue and converted | ||
| into heat for cutting, | ||
| solidification, bacteria | ||
| reduction and | ||
| desensitization. | ||
| Environment | ||
| of | ||
| Use | Hospital, clinic, and medical | |
| office setting | Hospital, clinic, and | |
| medical office setting | ||
| Size | 18cm x 16cm x 26cm | 182 x 197 x 189 mm |
| Shipping list | The product is composed | |
| of: | ||
| ● Mainframe | ||
| ● Fiber optic tip | ||
| ● Charging adaptor | ||
| ● Fiber optic cleaner | ||
| ● Fiber bender | ||
| ● Laser area symbol | ||
| ● Protection glasses | ● FONALaser mainframe | |
| including A control | ||
| unit including a | ||
| handpiece with a | ||
| manual switch | ||
| ● Handpiece cover | ||
| ● Fiber head pack | ||
| (including 1 x 200 μm | ||
| and 4 x 320 μm) | ||
| ● Fiber cutter | ||
| ● Disposable operation | ||
| head (including a | ||
| bending tool) | ||
| ● Protection glasses | ||
| ● Switch power supply | ||
| Software | MCU software | MCU software |
| Laser Class | IV (4) | IV (4) |
| Wavelength | 980nm ±20nm | 970 nm ± 15nm |
| Frequency | 1Hz to 100Hz | 1Hz to 100Hz |
| Output Power | 4.0 W Max CW / 8.0 W | 4.0 W Max CW / 7.0 W |
| Peak Power (Pulse Mode) | Peak Power (Pulse Mode) | |
| Pulse mode | Continuous | Continuous |
| Aiming Beam | Laser diode, 5 mW, | |
| 680nm±20nm, Class 1 | Laser diode, max 1 mW, | |
| 635-650nm, Class 1 | ||
| N.O.H.D. | 3.03 meters | 1.5 meters |
| Comparison | ||
| statement | The subject device has almost the same technological | |
| characteristics with the predicate device, and their slight | ||
| difference in Size, Aiming Beam, Wavelength and | ||
| N.O.H.D. will not affect the core usage of the devices or | ||
| validated by relevant standard evaluation or not | ||
| bringing new safety and effectiveness concerns, thus | ||
| will not affecting the substantial equivalence | ||
| comparison. their differences are not affecting the core | ||
| usage of the devices | ||
| The difference in Wavelength had verified the safety | ||
| characteristics by IEC 60825-1 and IEC 60601-2-22, and | ||
| the efficiency of subject device is better than predicate | ||
| device. It could be found in literature referred.[1] | ||
| Material Characteristics | ||
| Application part | Fiber optic tip | Fiber |
| Enclosure | ABS | Not know |
| Hand piece Cover | Silica gel | elasto-plastic |
| Safety & Effectiveness | ||
| Patient-Contacting | ||
| Materials | Fiber optic tip | Fiber |
| Electrical Safety | Verified according IEC | |
| 60601-1 | Not know | |
| EMC | Verified according IEC | |
| 60601-1-2 | Not know | |
| Performance Safety | Verified according IEC 60825-1 and IEC 60601-2-22 | Not know |
| Comparison statement | The safety and essential effectiveness of the subject device have been evaluated according to the FDA recognized standards. |
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Image /page/8/Picture/0 description: The image shows the logo for SOGA. The logo is in dark gray, with the letter A in the logo having a green triangle in the middle. Below the logo is the company name in Chinese characters. There is a horizontal line above and below the Chinese characters.
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Image /page/9/Picture/0 description: The image shows the logo for SOGA. The logo is in a dark gray color, with the letter A having a green triangle in the middle. Below the logo is the company name in Chinese characters.
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Image /page/10/Picture/0 description: The image shows the logo for SOGA. The logo is in a dark gray color, with the letter A having a green triangle in the middle. Underneath the logo is the company name in Chinese characters, with a line on either side of the name.
5.6.1 Comparison summary
First, the subject device (Model: ILaser I) enjoys identical classification and intended use with the predicate device, which forms the foundation of their substantial equivalence.
Secondly, the most technological characteristics have substantial equivalence difference is below:
| Difference item |
|---|
| Shipping list |
| Size |
| Wavelength |
| Aiming Beam |
| Frequency |
| Output power |
| N.O.H.D. |
| Enclosure material |
| Handpiece cover material |
5.7 Discussion of Tests Performed
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Image /page/11/Picture/1 description: The image shows the logo for SOGA. The logo is in a dark gray color, with the letter A in the logo having a green triangle in the middle. Below the logo is the company name in Chinese.
5.7.1 Clinical Test
Clinical testing was not performed for SOGALaser (Model: ILaser I) as part of the submission.
5.7.2 Non-Clinical Tests
The subject device was tested/analyzed according to the following standards in order to ensure its effectiveness and safety:
| | Standard
Designation
Number | Title of Standard |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Electrical Safety | IEC 60601-1 | Medical electrical
equipment Part 1:
General requirements
for basic safety and
essential performance |
| Electromagnetic
Compatibility | IEC 60601-1-2 | Medical Electrical
Equipment - Part 1-2:
General Requirements
For Basic Safety And
Essential Performance
– Collateral Standard:
Electromagnetic
Compatibility -
Requirements And
Tests |
| Performance
Safety and
Effectiveness | IEC 60825-1 | Safety of laser
products - Part 1:
Equipment
classification, and
requirements |
| | IEC 60601-2-22 | Medical electrical
equipment - Part 2-22: |
| | Particular
requirements for basic
safety and essential
performance of
surgical, cosmetic,
therapeutic and
diagnostic laser
equipment | |
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Image /page/12/Picture/0 description: The image shows the logo for SOGA. The logo is in a dark gray color, except for a small green triangle in the upper right corner of the A. Below the logo is the company name in Chinese characters.
5.8 Conclusion
From the above analysis, it is proper to conclude that the subject device (Model: ILaser I) will be as safe and effective for usage as the listed predicate devices that have already been on the U.S. market.
5.9 Release date
Apr. 11, 2022