(139 days)
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:.
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. 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. 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.
This document describes the regulatory submission for the Shenzhen Soga Technology Co., Ltd. Dental Diode Laser (Model: ILaser I). It focuses on demonstrating substantial equivalence to a predicate device, SIROLaser Advance (Model: FonaLaser), rather than presenting a study to prove acceptance criteria with specific performance metrics.
Here's an analysis based on the provided text, addressing the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity) for the device. Instead, it relies on demonstrating substantial equivalence to a predicate device through comparison of technological characteristics and adherence to recognized safety and performance standards. The "performance" reported is primarily that the device meets these safety and performance standards.
| Acceptance Criteria Category | Specific Criteria (from predicate comparison & standards) | Reported Device Performance |
|---|---|---|
| Classification and Intended Use | Identical classification (Class II, 21 CFR 878.4810) and intended use as the predicate device (Intra- and extra-oral surgery for various soft tissue procedures). | The subject device (SOGALaser, Model: ILaser I) has identical classification (GEX, NVK, Class II, 21 CFR 878.4810) and intended use compared to the predicate device (SIROLaser Advance, K103753). |
| Technological Characteristics | Substantially similar technological characteristics to the predicate device, with differences not affecting core usage or bringing new safety/effectiveness concerns. Expected parameters include Wavelength, Output Power, Frequency, Aiming Beam, Laser Class, N.O.H.D. (Nominal Ocular Hazard Distance). | Close matching to predicate: - Wavelength: 980nm ±20nm (vs. 970nm ±15nm for predicate). The document states this difference was verified for safety (IEC 60825-1, IEC 60601-2-22) and that the subject device's efficiency is better based on literature. - Frequency: 1Hz to 100Hz (same as predicate). - Output Power: 4.0 W Max CW / 8.0 W Peak Power (Pulse Mode) (vs. 4.0 W Max CW / 7.0 W Peak Power for predicate). - Aiming Beam: Laser diode, 5 mW, 680nm±20nm, Class 1 (vs. max 1 mW, 635-650nm, Class 1 for predicate). - Laser Class: IV (4) (same as predicate). - N.O.H.D.: 3.03 meters (vs. 1.5 meters for predicate). Other characteristics (Principle of Operation, Environment of Use, Software) are also compared and deemed substantially equivalent. |
| Safety and Performance Standards | Compliance with recognized international standards for medical electrical equipment safety, electromagnetic compatibility, and laser product safety. Expected standards include: - IEC 60601-1 (Electrical Safety) - IEC 60601-1-2 (Electromagnetic Compatibility) - IEC 60825-1 (Safety of laser products - Part 1) - IEC 60601-2-22 (Particular requirements for basic safety and essential performance of surgical laser equipment) | The device has been Verified to comply with: - IEC 60601-1 (Electrical Safety) - IEC 60601-1-2 (Electromagnetic Compatibility) - IEC 60825-1 (Performance Safety and Effectiveness) - IEC 60601-2-22 (Performance Safety and Effectiveness) |
| Sterilization Conditions | Specific conditions for sterilization of consumable components. | Consumable component (Fiber optic tip) requires sterilization at 121℃ (250°F) for 30 minutes. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. This submission is based on demonstrating substantial equivalence to a predicate device and adherence to recognized standards, not on a clinical trial with a "test set" of patients or data in the typical sense for performance evaluation (e.g., diagnostic accuracy).
- Data Provenance: The "data" provided relates to the technical specifications of the device and its predicate, and results from non-clinical testing performed in accordance with international standards. The country of origin for the subject device is China (Shenzhen, Guangdong).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. There was no "test set" with ground truth established by experts in the context of this 510(k) submission for this type of device. The evaluation relies on engineering, safety, and performance testing against established standards.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable, as there was no test set requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No, an MRMC comparative effectiveness study was not performed. This device is a laser surgical instrument, not an AI-assisted diagnostic tool for "human readers."
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device is a hardware surgical instrument, not an algorithm. Its performance is evaluated through physical and electrical safety, and functional testing, not standalone algorithmic performance.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The "ground truth" in this context is the successful demonstration of compliance with established international safety and performance standards (IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22). This relies on objective measurement and testing against the requirements set by these standards, rather than expert consensus on diagnostic images or pathology.
8. The Sample Size for the Training Set
- Sample Size: Not applicable. This device is a physical instrument, not an AI model requiring a training set of data.
9. How the Ground Truth for the Training Set was Established
- Ground Truth Establishment: Not applicable, as there is no training set for this device.
{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".
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) |
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}------------------------------------------------
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
{4}------------------------------------------------
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
{5}------------------------------------------------
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;.
| ComparisonItems | Subject Device:SOGALaser(Model: ILaser I) | Predicate Device:SIROLaser AdvanceModel: FONALaser(K103753) |
|---|---|---|
| Classification & Intended Use | ||
| Classification | GEX, NVKClass II21 CFR 878.4810 | GEXClass II21 CFR 878.4810 |
| Intended use | Intra- and extra-oralsurgery including incision,excision, hemostasis, | Intra- and extra-oralsurgery including incision,excision, hemostasis, |
5.6 Comparison of Technological Characteristics with the Predicate Device
{6}------------------------------------------------
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
{7}------------------------------------------------
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 theperiodontal pocket toimprove clinical indicesincluding gingival index,gingival bleeding index,probe depth, attachmentloss and tooth inability);pulpotomy; pulpotomy asadjunct to root canaltherapy; Fibroma removal;Gingival incision andexcision; Treatment ofcanker sores; herpeticulcers of the oral mucosa;Laser soft tissue curettage;Reduction of gingivalhypertrophy;. | inflamed and necrosedsoft tissue in theperiodontal pocket toimprove clinical indicesincluding gingival index,gingival bleeding index,probe depth, attachmentloss and tooth inability);pulpotomy; pulpotomy asadjunct to root canaltherapy; Fibroma removal;Gingival incision andexcision; Treatment ofcanker sores; herpeticulcers of the oral mucosa;Laser soft tissuecurettage; Reduction ofgingival hypertrophy;. | |
| Patient Population | For use in all patients | For use in all patients |
| Environment ofUse | For Dental surgeon | Prescription Use - Forprofessional |
| Patient Population | No restriction on theapplicable population | All Population |
| ComparisonStatement | The subject device enjoys the same classification andintended use with the predicate device. | |
| Technological Characteristics | ||
| Principle / Methodof Operation | The semiconductor laserdiode is excited by thegeneration power supply togenerate the laser, which iseffectively transmitted to | It is generated by a laserdiode in the control unitand is guided through aquartz fiber to thetreatment area. The laser |
| the treatment site throughthe fiber optic tip. | radiation is absorbed bythe tissue and convertedinto heat for cutting,solidification, bacteriareduction anddesensitization. | |
| EnvironmentofUse | Hospital, clinic, and medicaloffice setting | Hospital, clinic, andmedical office setting |
| Size | 18cm x 16cm x 26cm | 182 x 197 x 189 mm |
| Shipping list | The product is composedof:● Mainframe● Fiber optic tip● Charging adaptor● Fiber optic cleaner● Fiber bender● Laser area symbol● Protection glasses | ● FONALaser mainframeincluding A controlunit including ahandpiece with amanual switch● Handpiece cover● Fiber head pack(including 1 x 200 μmand 4 x 320 μm)● Fiber cutter● Disposable operationhead (including abending 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 |
| Comparisonstatement | The subject device has almost the same technologicalcharacteristics with the predicate device, and their slightdifference in Size, Aiming Beam, Wavelength andN.O.H.D. will not affect the core usage of the devices orvalidated by relevant standard evaluation or notbringing new safety and effectiveness concerns, thuswill not affecting the substantial equivalencecomparison. their differences are not affecting the coreusage of the devicesThe difference in Wavelength had verified the safetycharacteristics by IEC 60825-1 and IEC 60601-2-22, andthe efficiency of subject device is better than predicatedevice. 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-ContactingMaterials | Fiber optic tip | Fiber |
| Electrical Safety | Verified according IEC60601-1 | Not know |
| EMC | Verified according IEC60601-1-2 | 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. |
{8}------------------------------------------------
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.
{9}------------------------------------------------
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.
{10}------------------------------------------------
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
{11}------------------------------------------------
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:
| StandardDesignationNumber | Title of Standard | |
|---|---|---|
| Electrical Safety | IEC 60601-1 | Medical electricalequipment Part 1:General requirementsfor basic safety andessential performance |
| ElectromagneticCompatibility | IEC 60601-1-2 | Medical ElectricalEquipment - Part 1-2:General RequirementsFor Basic Safety AndEssential Performance– Collateral Standard:ElectromagneticCompatibility -Requirements AndTests |
| PerformanceSafety andEffectiveness | IEC 60825-1 | Safety of laserproducts - Part 1:Equipmentclassification, andrequirements |
| IEC 60601-2-22 | Medical electricalequipment - Part 2-22: | |
| Particularrequirements for basicsafety and essentialperformance ofsurgical, cosmetic,therapeutic anddiagnostic laserequipment |
{12}------------------------------------------------
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
§ 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.