(438 days)
Dental Soft Tissue Indications: Incision, excision, vaporization, ablation and coagulation of oral soft tissues, including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications: Excisional and incisional biopsies, Exposure of unerupted teeth, Fibroma removal, Frenectomy, Frenotomy, Gingival troughing for crown impressions, Gingivectomy, Gingivoplasty, Gingival incision and excision, Hemostasis and coagulation, Implant recovery, Incision and drainage of abscess, Leukoplakcia, Operculectomy, Oral papillectomies, Pulpotomy, Pulpotomy as an adjunct to root canal therapy, Reduction of gingival hypertrophy, Soft tissue crown lengthening, Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa, Vestibuloplasty, Tissue retraction for impression. Laser Periodontal Procedures, including: Laser soft tissue curettage, 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 mobility).
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 Fiber optic tip and the handpiece cover require sterilization prior to use.
This document is a 510(k) premarket notification for a Class II medical device, the Dental Diode Laser, SOGA Laser, ILaser II. It focuses on demonstrating substantial equivalence to a predicate device (iLase™ by Biolase Technology, Inc., K093852) rather than proving meeting specific acceptance criteria through a performance study against a defined ground truth.
Therefore, the requested information regarding acceptance criteria, device performance, sample size, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment (which are typical for AI/ML-driven device performance studies) cannot be extracted from this document, as it describes a traditional medical device (a laser) and its regulatory submission based on substantial equivalence.
The document details the device's technical specifications and compares them to a predicate device to argue for substantial equivalence in safety and effectiveness, based primarily on non-clinical testing against recognized standards (e.g., IEC, ISO). Clinical testing was explicitly stated as not performed for this submission.
Here's what can be extracted based on the provided document, even though it doesn't align with the typical "acceptance criteria and study that proves the device meets the acceptance criteria" format for AI/ML devices:
1. A table of acceptance criteria and the reported device performance:
This document does not present quantitative performance metrics against specific acceptance criteria for a "study" in the way an AI/ML device would. Instead, it compares technical specifications to a predicate device to demonstrate substantial equivalence. The "acceptance criteria" here are effectively "being substantially equivalent to the predicate device in terms of safety and effectiveness."
| Comparison Item | Acceptance Criteria (based on Predicate Device) | Reported Device Performance (SOGA Laser, ILaser II) |
|---|---|---|
| Classification | GEX, Class II (21 CFR 878.4810) | GEX, Class II (21 CFR 878.4810) - Meets |
| Intended Use | Incision, excision, vaporization, ablation and coagulation of oral soft tissues, including marginal and inter-dental gingival and epithelial lining of free gingiva, and specific indications (listed on page 2) | Identical list of indications for use. - Meets |
| Patient Population | For use in all patients | For use in all patients; No restriction on the applicable population - Meets |
| Environment of Use | Hospital, clinic, and medical office setting (Predicate: Prescription Use - For professional) | Hospital, clinic, and medical office setting; For Dental surgeon - Meets |
| Principle of Operation | Energy delivered to treatment site via single-use fiber optic tip assembly. | Semiconductor laser diode excited by generation power supply to generate laser, effectively transmitted to treatment site through optical fiber tip. Comparison statement notes "almost the same technological characteristics" and states the difference "will not affect the core usage" and efficiency was "able to reach an equivalence level". Supported by literature [1] (not provided in this excerpt). - Deemed Equivalent |
| Size | 20.5 cm x φ 1.90 cm | φ18mm x 200mm. Comparison statement notes "slight difference in size" will not affect substantial equivalence. - Deemed Equivalent |
| Wavelength | 940 nm ± 10nm | 980nm ±20nm. Comparison statement notes differences verified by IEC 60825-1 and IEC 60601-2-22, and efficiency able to reach equivalence level. Supported by literature [1]. - Deemed Equivalent |
| Output Power | 3.0 W Max CW / 5.0 W Peak Power (Pulse Mode) | 3.0 W Max CW / 5.0 W Peak Power (Pulse Mode) - Meets |
| Power Accuracy | ± 20% | ± 5%. Comparison statement notes "slight difference in... Power Accuracy will not affect the core usage... or not bringing new safety and effectiveness concerns." - Better Performance, Deemed Equivalent |
| Pulse Mode | Continuous | Continuous - Meets |
| Duty Cycle | 9.09%~83.3% | 9.09%~83.3% - Meets |
| Aiming Beam | Laser diode, max 1 mW, 625-670nm, Class 1 | Laser diode, max 2 mW, 650nm±20nm, Class 1. Comparison statement notes "slight difference in... Aiming Beam and Power Accuracy will not affect the core usage... or not bringing new safety and effectiveness concerns." - Deemed Equivalent |
| N.O.H.D. | 2.61 meters | 3.03 meters. Comparison statement notes difference does not affect substantial equivalence. - Deemed Equivalent |
| Safety & Effectiveness | Verified according to relevant standards (e.g., Electrical, EMC, Performance, Biocompatibility). | Verified according to IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22, ISO 10993-5, ISO 10993-10. - Demonstrated Compliance with Standards |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable. No clinical test set or data set for performance evaluation in the AI/ML sense was used. The submission relies on technical comparisons and non-clinical testing.
- Data Provenance: Not applicable for a "test set." The document refers to "literature referred [1]" for demonstrating efficiency equivalence but does not provide details of this literature.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No ground truth establishment for a test set was performed, as it was a technical comparison for substantial equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No adjudication was necessary as no test set requiring ground truth labeling was used.
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:
- No MRMC study was done (or mentioned). This is a physical device (laser), not an AI-based diagnostic or assistive software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical laser device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. The basis for safety and effectiveness is "substantial equivalence" to a legally marketed predicate device, supported by compliance with international electrical, laser, and biocompatibility standards.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
July 1, 2022
Shenzhen Soga Technology Co., Ltd. Tse Adrian Quality Manager D906, Yinxing Technology Building No. 1301, Sightseeing Road, Xinlan Community, Guanlan Street Shenzhen, Guandong 518110 CHINA
Re: K211150
Trade/Device Name: Dental diode laser, SOGA Laser, ILaser II 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 Dated: June 21, 2022 Received: June 21, 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.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211150
Device Name
Dental Diode Laser, SOGA Laser, ILaser II
| Indications for Use ( Describe ) |
|---|
| Dental Soft Tissue Indications: |
| Incision, excision, vaporization, ablation and coagulation of oral soft tissues, including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications: |
| Excisional and incisional biopsies |
| Exposure of unerupted teeth |
| Fibroma removal |
| Frenectomy |
| Frenotomy |
| Gingival troughing for crown impressions |
| Gingivectomy |
| Gingivoplasty |
| Gingival incision and excision |
| Hemostasis and coagulation |
| Implant recovery |
| Incision and drainage of abscess |
| Leukoplakcia |
| Operculectomy |
| Oral papillectomies |
| Pulpotomy |
| Pulpotomy as an adjunct to root canal therapy |
| Reduction of gingival hypertrophy |
| Soft tissue crown lengthening |
| Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa. |
| Vestibuloplasty |
| Tissue retraction for impression |
| Laser Periodontal Procedures, including: |
| Laser soft tissue curettage |
| 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 mobility). |
| 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.
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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, except for a small portion of the letter A, which is in green. Below the logo, there are some Chinese characters.
005 510(k) Summary K211150
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, SOGALaser ●
- Model: ILaser II
- Common Name: Dental diode laser
- Classification requlation: Regulation number: 21 CFR 878.4810 Regulation Description: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulation Medical Specialty: General & Plastic Surgery
- Review Panel: General & Plastic Surgery ●
- Product Code: GEX
- Regulation Number: 21 CFR 878.4810
- Device Class: Class II
- Submission number: K211150
5.3 Predicate Device Information
Primary Predicate Device: iLase™
Manufacturer: Biolase Technology, Inc.
510(k) number: K093852
Indication of 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, except for a small portion of the letter A, which is in green. Below the logo, there are Chinese characters.
Dental Soft Tissue Indications:
Incision, excision, vaporization, ablation and coagulation of oral soft tissues, including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications:
- Excisional and incisional biopsies ●
- Exposure of unerupted teeth ●
- Fibroma removal ●
- Frenectomy
- Frenotomy
- Gingival troughing for crown impressions ●
- Gingivectomy ●
- Gingivoplasty ●
- Gingival incision and excision ●
- Hemostasis and coaqulation ●
- Implant recovery
- Incision and drainage of abscess ●
- Leukoplakcia
- Operculectomy ●
- Oral papillectomies ●
- Pulpotomy ●
- Pulpotomy as an adjunct to root canal therapy ●
- Reduction of gingival hypertrophy ●
- Soft tissue crown lengthening
- Treatment of canker sores, herpetic and aphthous ulcers of the ● oral mucosa.
- Vestibuloplasty ●
- Tissue retraction for impression ●
Laser Periodontal Procedures, including:
- Laser soft tissue curettage ●
- Laser removal of diseased, infected, inflamed and necrosed soft ● tissue within the periodontal pocket
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Image /page/6/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, there are four Chinese characters in a smaller font size.
- 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 mobility).
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 Fiber optic tip and the handpiece cover require sterilization prior to use.
5.5 Indications for Use
Dental Soft Tissue Indications:
Incision, excision, vaporization, ablation and coagulation of oral soft tissues, including marqinal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications:
- Excisional and incisional biopsies ●
- Exposure of unerupted teeth ●
- Fibroma removal
- Frenectomy
- Frenotomy ●
- Gingival troughing for crown impressions ●
- Gingivectomy ●
- Gingivoplasty ●
- Gingival incision and excision ●
- Hemostasis and coagulation ●
- Implant recovery
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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's name in Chinese characters. The "A" in SOGA has a green triangle in the middle.
- Incision and drainage of abscess
- Leukoplakcia ●
- Operculectomy ●
- Oral papillectomies
- Pulpotomy ●
- Pulpotomy as an adjunct to root canal therapy
- Reduction of gingival hypertrophy ●
- Soft tissue crown lengthening ●
- Treatment of canker sores, herpetic and aphthous ulcers of the ● oral mucosa.
- Vestibuloplasty ●
- Tissue retraction for impression ●
Laser Periodontal Procedures, including:
- Laser soft tissue curettage ●
- 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 mobility).
5.6 Comparison of Technological Characteristics with the Predicate Device
| Comparison Items | Subject Device:SOGALaser(Model: ILaser II) | PredicateDevice 1:Dentaldiode laser(K093852) |
|---|---|---|
| Classification & Intended Use | ||
| Classification | GEXClass II | GEXClass II |
| 21 CFR 878.4810 | 21 CFR878.4810 | |
| Intended use | Intended to incision,excision, vaporization,ablation and coagulationof oral soft tissuesincluding marginal andinter-dental gingival andepithelial lining of freegingiva. | Incision,excision,vaporization,ablation andcoagulationof oral softtissues,includingmarginal andinter-dentalgingival andepitheliallining of freegingiva andthe followingspecificindications:(For specificrefer toAttachmentE) |
| Patient Population | For use in all patients | For use in allpatients |
| Environment of Use | For Dental surgeon | PrescriptionUse - Forprofessional |
| Patient Population | No restriction on theapplicable population | AllPopulation |
| ComparisonStatement | The subject device enjoysthe same classification | |
| and intended use with the | ||
| predicate device. | ||
| Technological Characteristics | ||
| Principle / Method of Operation | The semiconductor laserdiode is excited by thegeneration power supplyto generate the laser,which is effectivelytransmitted to thetreatment site through theoptical fiber treatmenthead. | The energyis deliveredto thetreatmentsite via asingle-usefiber optictip assembly. |
| Environment of Use | Hospital, clinic, andmedical office setting | Hospital,clinic, andmedicaloffice setting |
| Size | φ18mmx200mm | 20.5 cm Χφ1.90 cm |
| Shipping list | Main body, Wireless power supply, Fiber optic tip, Laser Safety Glasses (Clinician), Laser Safety Glasses (Patient), Cleaning pen, Silicon cover. Instruction | iLase Main Body, Power Supply – Charging Station, iLase Cover, iLase Rechargeable Battery, |
| TipInitiationBlocks,LaserSafetyGlasses(Clinician),LaserSafetyGlasses(Patient),iLaseCleaningKit,UserManual | ||
| Software | MCU software | MCU software |
| Laser Class | IV (4) | IV (4) |
| Wavelength | 980nm ±20nm | 940 nm ± 10nm |
| Output Power | 3.0 W Max CW / 5.0 W Peak Power (Pulse Mode) | 3.0 W Max CW / 5.0 W Peak Power (Pulse Mode) |
| Power Accuracy | ± 5% | ± 20% |
| Pulse mode | Continuous | Continuous |
| Duty cycle | 9.09%~83.3% | 9.09%~83.3% |
| Aiming Beam | Laser diode, max 2 mW, | Laser diode, |
| 650nm±20nm, Class 1 | max 1 mW,625-670nm,Class 1 | |
| N.O.H.D. | 3.03 meters | 2.61 meters |
| Comparison statement | The subject device has almost the sametechnological characteristics with thepredicate device, and their slightdifference in size, Aiming Beam andPower Accuracy will not affect the coreusage of the devices or validated byrelevant standard evaluation or notbringing new safety and effectivenessconcerns, thus will not affecting thesubstantial equivalence comparison. theirdifferences are not affecting the coreusage of the devicesThe difference in Wavelength verified thesafety characteristics by IEC 60825-1 andIEC 60601-2-22, and the efficiency of thesubject device was able to reach anequivalence level of the predicate device.It could be found in the literaturereferred.[1] | |
| Material Characteristics | ||
| Application part | Fiber optic | Fiber optic |
| Enclosure | 316L Stainless steel | Not know |
| Cover | Silica gel | Metal |
| Safety & Effectiveness | ||
| Patient-Contacting Materials | Fiber optic | Fiber optic |
| Electrical Safety | Verified according to IEC | Not know |
| 60601-1 | ||
| EMC | Verified according to IEC60601-1-2 | Not know |
| Performance Safety | Verified according to IEC60825-1 and IEC 60601-2-22 | Not know |
| Biocompatibility | Verified according to ISO10993-5 and ISO 10993-10 | Not know |
| Comparison statement | The substantial equivalence of the subjectdevice has been evaluated according tothe FDA recognized standards. |
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Image /page/8/Picture/0 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. The logo is simple and modern.
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Image /page/9/Picture/0 description: The image contains a logo for SOGA. The logo is in a dark gray color, except for the triangle in the letter A, which is green. Below the logo, there are four Chinese characters, which are separated by two short horizontal lines.
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Image /page/10/Picture/0 description: The image shows the logo for SOGA. The logo is in gray and green. The text below the logo is in Chinese.
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Image /page/11/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.
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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, and the letter A has a green triangle in the middle. Below the logo is the company name in Chinese.
5.6.1 Comparison summary
First, the subject device (Model: ILaser II) 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 |
| Wavelength |
| Power Accuracy |
| Aiming Beam |
| N.O.H.D. |
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Image /page/13/Picture/0 description: The image shows the logo for SOGA, a technology company. The logo consists of the word "SOGA" in a bold, sans-serif font, with the letter "A" stylized to resemble a mountain peak. The color of the logo is primarily gray, with a small green triangle at the top of the "A". Below the word "SOGA" is the company's name in Chinese characters.
Enclosure material
Handpiece cover material
5.7 Discussion of Tests Performed
5.7.1 Clinical Test
Clinical testing was not performed for SOGALaser (Model: ILaser II) 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 substantial equivalence:
| 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 and | IEC 60825-1 | Safety of laserproducts - Part 1: |
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Image /page/14/Picture/0 description: The image shows the logo for SOGA. The logo consists of the word "SOGA" in a dark gray, sans-serif font. The "A" in "SOGA" has a green triangle in the middle. Below the word "SOGA" is the company's name in Chinese characters.
| Effectiveness | ||
|---|---|---|
| Equipmentclassification, andrequirements | ||
| IEC 60601-2-22 | Medical electricalequipment - Part 2-22:Particularrequirements for basicsafety and essentialperformance ofsurgical, cosmetic,therapeutic anddiagnostic laserequipment | |
| Biocompatibility | ISO 10993-5 | Biological evaluationof medical devices –Part 5: Tests for invitro cytotoxicity |
| ISO 10993-10 | Biological evaluationof medical devices –Part 10: Test forirritation and skinsensitization |
5.8 Conclusion
From the above analysis, it is proper to conclude that the subject device (Model: ILaser II) will be as safe and effective for usage as the listed predicate devices that have already been on the U.S. market.
5.9 Date the Summary was prepared: June 30, 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.