Dental Diode Laser System

K180967 · Lazon Medical Laser Co., Ltd. · GEX · Jul 11, 2018 · General, Plastic Surgery

Device Facts

• Record ID: K180967
• Device Name: Dental Diode Laser System
• Applicant: Lazon Medical Laser Co., Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jul 11, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The SOLASE dental diode laser is a surgical and therapeutic device produced by Lazon Medical Laser Co., Ltd., designed for dental soft tissue indications, laser periodontal procedures, as well as teeth whitening and pain relief. It cannot be used for oral hard tissue.

Device Story

Dental diode laser system (models SOLASE-808, SOLASE-976) uses laser diodes to generate infrared light (808nm or 976nm) delivered via optical fiber to oral soft tissues. Device operates in continuous or pulse modes for surgical (ablation, incision, coagulation) and therapeutic (whitening, pain relief) applications. Class 4 laser requires operation by trained/qualified personnel in dental clinical settings. Physician/dentist uses device to perform soft tissue procedures or provide therapeutic heating; output affects tissue via thermal energy. Benefits include precise soft tissue management, hemostasis, and temporary pain relief. Device is not for hard tissue use.

Clinical Evidence

No clinical data; bench testing only. Compliance verified via electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), laser safety (IEC 60601-2-22, IEC 60825-1), and biocompatibility (ISO 10993-5, ISO 10993-10). Performance testing confirmed peak power output meets specifications.

Technological Characteristics

Class 4 diode laser (AlGaAs medium); wavelengths 808nm or 976nm. Fiber optic delivery (200-400µm). Materials: stainless steel, aluminum, quartz, polypropylene. Power: 100-240VAC, 50-60Hz. Continuous and pulse modes. Aiming beam: 650nm, 2mW. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1, ISO 10993.

Indications for Use

Indicated for incision, excision, vaporization, ablation, and coagulation of oral soft tissues (e.g., fibroma removal, frenectomy, frenotomy, gingival troughing, gingivectomy, gingivoplasty, hemostasis, implant recovery, abscess drainage, operculectomy, pulpotomy, soft tissue crown lengthening, treatment of herpetic/aphthous ulcers); laser periodontal procedures (removal of diseased/inflamed/necrosed tissue, sulcular debridement); light activation for teeth whitening; and topical heating for temporary relief of minor muscle/joint pain, stiffness, arthritis pain, muscle spasm, sprains, and muscular back pain, and temporary increase in local blood circulation/muscle relaxation.

Regulatory Classification

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.

Predicate Devices

• Epic 10 Diode Laser System (K121286)

Reference Devices

• Sapphire ST Portable Laser (K103667)

Submission Summary (Full Text)

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July 11, 2018

Lazon Medical Laser Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 Cn

Re: K180967

Trade/Device Name: Dental Diode Laser System, Models: Solace-808 and Solace-976 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 3, 2018 Received: April 13, 2018

Dear Diana Hong:

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 mav, therefore, market the device, subject to the general controls provisions of the Act. 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.

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Binita S. Ashar -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K180967

Device Name Dental Diode Laser System Models: SOLASE-808 and SOLASE-976

#### Indications for Use (Describe)

The indications for use of the subject device are given below.

1. Dental soft tissue indications

Incision, excision, vaporization, ablation of oral soft tissues including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications:

- fiborma removal
- frenectomy
- frenotomy
- gingival troughing for crown impressions
- gingivectomy
- gingivoplasty
- hemostasis and coagulation
- implant recovery
- incision and drainage of abscess
- operculectomy
- pulpotomy
- soft tissue crown lengthening
- treatment of herpetic and aphthous ulcers of the oral mucosa.
- 2. Laser periodontal procedures
- 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 bleeding index, probe depth, attachment loss and tooth mobility.)
- 3. Whitening
- light activation for bleaching materials for teeth whitening
- laser-assisted whitening/bleach of teeth
- 4. Pain Relief

- topical heating for the purpose of elevating tissue temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle

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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# 510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: K180967

- 1. Date of Preparation: 7/10/2018
- 2. Sponsor Identification

## Lazon Medical Laser Co., Ltd. No.123, Hezuo Street, Dadong District, Shenyang, 110179, Liaoning, China.

Establishment Registration Number: Not yet registered

Contact Person: Gen Cheng Position: General Manager Tel: [phone] Email: gen,[e-mail]

- 3. Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Mr. Chengyu Wang (Alternative Contact Person)

Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China

Tel: [phone], Fax: [phone] Email: [e-mail]

- Identification of Proposed Device 4.
Device Name: Dental Diode Laser System Model: SOLASE-808 and SOLASE-976 Common Name: Diode Laser

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#### Regulatory Information

Classification Name: Powered Laser Surgical Instrument Classification: II Product Code: GEX Regulation Number: 21 CFR 878.4810 Review Panel: General and Plastic Surgery

Indications for Use:

The indications for use of the subject device are given below.

- 1. 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:

- fiborma removal
- frenectomy
- frenotomy
- gingival troughing for crown impressions
- gingivectomy
- gingivoplasty
- hemostasis and coagulation
- implant recovery
- incision and drainage of abscess
- operculectomy
- pulpotomy
- soft tissue crown lengthening
- treatment of herpetic and aphthous ulcers of the oral mucosa.

#### 2. Laser periodontal procedures

- 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 bleeding index, probe depth, attachment loss and tooth mobility.)

#### 3. Whitening

- light activation for bleaching materials for teeth whitening
- laser-assisted whitening/bleach of teeth
- 4. Pain Relief

- topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle

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and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and strains, and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle.

Device Description

The SOLASE dental diode laser is a surgical and therapeutic device produced by Lazon Medical Laser Co., Ltd., designed for dental soft tissue indications, laser periodontal procedures, as well as teeth whitening and pain relief. It cannot be used for oral hard tissue.

The SOLASE laser uses a laser diode as the beam source to radiate invisible infrared light, which is delivered to the operating area by optical fiber. It can generate a short laser pulse up to 10us of interval. The SOLASE laser provides two different models with two different wavelengths - 808nm and 976mm, to meet customers' various requirements.

The SOLASE laser is a Class 4 laser product which may cause injuries in improper handling. Therefore, it MUST be operated only by trained and qualified personnel.

- ડ. Identification of Predicate Device and Reference Device
Predicate Device 510(k) Number: K121286 Product Name: Epic 10 Diode Laser System Model: Epic 10 Manufacturer: Biolase Technology, Inc.

Reference Device 510(k) Number: K103667 Product Name: Sapphire ST Portable Laser Manufacturer: Denmat Holdings LLC.

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#### 6. Non-Clinical Test Conclusion

Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

- A AAMI/ANSI ES 60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
- A IEC 60601-1-2:2014, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility- Requirements and tests
- A IEC 60601-2-22:2012, Medical Electrical Equipment - Part 2-22: Particular Requirements For Basic Safety And Essential Performance Of Surgical, Cosmetic, Therapeutic And Diagnostic Laser Equipment.
- > IEC 60825-1:2014, Safety of laser products - Part 1: Equipment classification and requirements.
- > ISO 10993-5:2009 Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin A sensitization
- A Performance data showing that the difference between the set average peak power and the measured average peak power meets performance criterion for the range of laser pulse specifications.
- 7. Clinical Test Conclusion

No clinical study is included in this submission.

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#### 8. Substantially Equivalent (SE) Comparison

| | Proposed Device | Predicate Device | Reference Device |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ITEM | | K121286 | K103667 |
| Product Code | GEX | GEX | GEX |
| Regulation<br>Number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 |
| Class | II | II | II |
| Indications for<br>Use | 1. Dental soft tissue<br>indications<br>Incision, excision,<br>vaporization, ablation<br>and coagulation of oral<br>soft tissues including<br>marginal and inter-dental<br>gingival and epithelial<br>lining of free gingiva<br>and the following<br>specific indications:<br>- fibroma removal<br>- frenectomy<br>- frenotomy<br>- gingival troughing for<br>crown impressions<br>- gingivectomy<br>- gingivoplasty<br>- hemostasis and<br>coagulation<br>- implant recovery<br>- incision and drainage<br>of abscess<br>- operculectomy<br>- pulpotomy-soft tissue<br>crown<br>lengthening-treatme<br>nt of herpetic and<br>aphthous ulcers of | 1. Dental Soft Tissue<br>Indications<br>Incision, excision,<br>vaporization, ablation and<br>coagulation of oral soft<br>tissues including marginal<br>and inter-dental gingival and<br>epithelial lining of free<br>gingiva and the following<br>specific indications:<br>* Excisional and incisional<br>biopsies<br>* Exposure of unerupted<br>teeth<br>* Fibroma removal<br>* Frenectomy<br>* Frenotomy<br>* Gingival troughing for<br>crown impressions<br>* Gingivectomy<br>* Gingivoplasty<br>* Gingival incision and<br>excision<br>* Hemostasis and coagulation<br>* Implant recovery<br>* Incision and drainage of | The Sapphire ST Portable<br>Diode Laser is intended for<br>use in dental intraoral soft<br>tissue general, oral<br>maxilla-facial and cosmetic<br>surgery. It is intended for<br>ablating, incising, excising,<br>vaporizing and coagulation of<br>soft tissues using a fiber optic<br>delivery system. Indications<br>include excision and incision<br>biopsies;, hemostatic<br>assistance; treatment of<br>aphthous ulcers; frenectomy;<br>frenotomy; gingival incision<br>and excision; gingivectomy;<br>gingivoplasty; incising and<br>draining abscesses;<br>operculectomy; oral<br>papillectomy; removal of<br>fibromias; Soft tissue crown<br>lengthening; sulcular<br>debridement (removal of<br>diseased or inflamed soft<br>tissue in the periodontal<br>pocket); tissue retraction |
| | | | |
| the oral mucosa. | abscess | for impression; | |
| | * Leukoplakia | vestibuloplasty, and light | |
| | * Operculectomy | activation of bleaching | |
| | * Oral papillectomnies | materials for teeth whitening, | |
| | * Pulpotomy | laser-assisted bleaching | |
| | * Pulpotomy as an adjunct to | /whitening of teeth. | |
| | 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 | | |
| 2. Laser periodontal<br>procedures | 2. Laser Periodontal<br>Procedures | | |
| - laser removal of<br>diseased, infected,<br>inflamed and necrosed<br>soft tissue within the<br>periodontal pocket<br>- sulcular debridement<br>(removal of diseased,<br>infected, inflamed and<br>necrosed soft tissue in<br>the periodontal pocket to<br>improve clinical indices<br>including gingival index,<br>gingival bleeding index,<br>probe depth, attachment<br>loss and tooth mobility.) | * Laser soft tissue curettage<br>* Laser removal of diseased,<br>infected, inflamed and<br>necrosed soft tissue within<br>the periodontal pocket<br>* Sulcular debridement<br>(removal of diseased,<br>infected, inflamed and<br>necrosed soft tissue in the<br>periodontal pocket to<br>improve clinical indices<br>including gingival index,<br>gingival bleeding index,<br>probe depth, attachment loss<br>and tooth mobility.) | | |
| | 3. Whitening<br>Light activation for<br>-<br>bleaching materials for<br>teeth whitening<br>*<br>Laser-assisted<br>whitening/bleaching<br>of<br>teeth<br>4. Pain Relief<br>- Topical heating for the<br>purpose of elevating<br>tissue temperature for a<br>temporary<br>relief<br>of<br>minor muscle and joint<br>pain and stiffness, minor<br>arthritis pain, or muscle<br>spasm, minor sprains<br>and strains, and minor<br>muscular back pain; the<br>temporary increase in<br>local blood circulation;<br>the temporary relaxation<br>of muscle. | 3. Whitening<br>* Light activation for<br>bleaching materials for teeth<br>whitening<br>* Laser-assisted<br>whitening/bleaching of teeth<br>4. Pain Relief<br>* Topical heating for the<br>purpose of elevating tissue<br>temperature for a temporary<br>relief of minor muscle and<br>joint pain and stiffness, minor<br>arthritis pain, or muscle<br>spasm, minor sprains and<br>strains, and minor muscular<br>back pain; the temporary<br>increase in local blood<br>circulation; the temporary<br>relaxation of muscle. | |
| Model | SOLASE-808 and<br>SOLASE-976…