← Product Code [GEX](/productcode/GEX) · K180967 # Dental Diode Laser System (K180967) _Lazon Medical Laser Co., Ltd. · GEX · Jul 11, 2018 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K180967 ## Device Facts - **Applicant:** Lazon Medical Laser Co., Ltd. - **Product Code:** [GEX](/productcode/GEX.md) - **Decision Date:** Jul 11, 2018 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4810 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **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. ## Regulatory 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](/device/K121286.md)) ## Reference Devices - Sapphire ST Portable Laser ([K103667](/device/K103667.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. 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); {1}------------------------------------------------ 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 {2}------------------------------------------------ ## 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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. {3}------------------------------------------------ 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." {4}------------------------------------------------ # 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: +86-24-88327588 Email: gen,cheng@lazonlaser.com - 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: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net - Identification of Proposed Device 4. Device Name: Dental Diode Laser System Model: SOLASE-808 and SOLASE-976 Common Name: Diode Laser {5}------------------------------------------------ #### 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 {6}------------------------------------------------ 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. {7}------------------------------------------------ #### 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. {8}------------------------------------------------ #### 8. Substantially Equivalent (SE) Comparison | | Proposed Device | Predicate Device | Reference Device | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | ITEM | | K121286 | K103667 | | Product Code | GEX | GEX | GEX | | Regulation
Number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | | Class | II | II | II | | Indications for
Use | 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:
- fibroma 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-treatme
nt of herpetic and
aphthous ulcers of | 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:
* 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 | The Sapphire ST Portable
Diode Laser is intended for
use in dental intraoral soft
tissue general, oral
maxilla-facial and cosmetic
surgery. It is intended for
ablating, incising, excising,
vaporizing and coagulation of
soft tissues using a fiber optic
delivery system. Indications
include excision and incision
biopsies;, hemostatic
assistance; treatment of
aphthous ulcers; frenectomy;
frenotomy; gingival incision
and excision; gingivectomy;
gingivoplasty; incising and
draining abscesses;
operculectomy; oral
papillectomy; removal of
fibromias; Soft tissue crown
lengthening; sulcular
debridement (removal of
diseased or inflamed soft
tissue in the periodontal
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
procedures | 2. Laser Periodontal
Procedures | | | | - 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.) | * 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.) | | | | | 3. Whitening
Light activation for
-
bleaching materials for
teeth whitening
*
Laser-assisted
whitening/bleaching
of
teeth
4. Pain Relief
- Topical heating for the
purpose of elevating
tissue temperature for a
temporary
relief
of
minor muscle 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. | 3. Whitening
* Light activation for
bleaching materials for teeth
whitening
* Laser-assisted
whitening/bleaching of teeth
4. Pain Relief
* Topical heating for the
purpose of elevating tissue
temperature for a temporary
relief of minor muscle 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. | | | Model | SOLASE-808 and
SOLASE-976… --- **Source:** [https://fda.innolitics.com/device/K180967](https://fda.innolitics.com/device/K180967) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com