Who is the manufacturer of D-Laser Blue, D-Laser 16?

Guilin Woodpecker Medical Instrument Co., Ltd. filed the 510(k) submission for D-Laser Blue, D-Laser 16 (K210367).

What is the FDA product code for D-Laser Blue, D-Laser 16?

NVK. It is classified under 21 CFR 878.4810 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for D-Laser Blue, D-Laser 16?

510(k) clearance (submission type: Traditional).

What are the predicate devices for D-Laser Blue, D-Laser 16?

SIROLaser Blue (K180044); SIROLaser Advance+ (K170500).

Who can help prepare an FDA 510(k) submission like D-Laser Blue, D-Laser 16?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

D-Laser Blue, D-Laser 16

K210367 · Guilin Woodpecker Medical Instrument Co., Ltd. · NVK · Mar 10, 2022 · General, Plastic Surgery

Device Facts

Record ID	K210367
Device Name	D-Laser Blue, D-Laser 16
Applicant	Guilin Woodpecker Medical Instrument Co., Ltd.
Product Code	NVK · General, Plastic Surgery
Decision Date	Mar 10, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4810
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

D-Laser Blue and D-Laser 16 are intended for intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue including marginal and epithelial lining of free gingiva and are indicated for: frenectomy; frenotomy; implant recovery; gingivectomy; gingivectomy; gingivoplasty; gingival troughing; crown lengthening; hemostasis of donor site; removal of granulation tissue; laser assisted flap surgery; debridement of diseased epithelial lining: incisions and draining of abscesses: tissue retraction for impressions: papillectory; 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 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. Whitening: D-Laser Blue and D-Laser 16 are indicated for light activation for bleaching materials for teeth whitening and for laser-assisted whitening/bleaching of teeth. Low Level Laser Therapy: D-Laser Blue and D-Laser 16 are intended to emit energy in the red and infrared spectrum to provide topical heating for the purpose of elevating tissue temperary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, and for the temporary increase in local blood circulation and/or temporary relaxation of muscles.

Device Story

D-Laser Blue and D-Laser 16 are dental diode laser systems used for soft tissue surgery, periodontal treatment, teeth whitening, and low-level laser therapy. The devices consist of a main unit with a semiconductor laser, control system, and capacitive touch screen. They emit laser energy in blue, red, and infrared spectra (D-Laser Blue) or red and infrared (D-Laser 16) via a fiber transmission system. Operated by dental professionals in clinical settings, the device uses a handpiece with a finger switch or wireless footswitch for activation. The laser energy vaporizes, carbonizes, or solidifies soft tissue to perform procedures like frenectomy, gingivectomy, and sulcular debridement. The output provides hemostasis and tissue ablation, aiding in surgical precision and patient recovery. The device includes preset treatment procedures and an automatic shutdown safety mechanism. Benefits include reduced surgical difficulty, cross-infection prevention via autoclavable components, and non-invasive pain relief through topical heating.

Clinical Evidence

No human clinical data was required. Substantial equivalence was demonstrated through bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), laser safety (IEC 60825-1), performance testing (IEC 60601-2-22), usability engineering (IEC 62366), software validation (IEC 62304), and biocompatibility (ISO 10993-5). Cutting efficiency was compared to predicate devices.

Technological Characteristics

Solid-state diode laser system. Wavelengths: 976nm, 650nm, 450nm (D-Laser Blue); 976nm, 650nm (D-Laser 16). Emission: Continuous wave and chopped (1Hz-20kHz). Power: 0.2W-4W (976nm), 25mW-200mW (650nm), 0.2W-3W (450nm). Interface: Color capacitive touch screen. Connectivity: Wireless footswitch. Sterilization: Autoclavable handpiece sleeve and fiber tips. Biocompatibility: ISO 10993-5 compliant.

Indications for Use

Indicated for intra- and extra-oral soft tissue surgery, periodontal debridement, pulpotomy, teeth whitening, and low-level laser therapy for temporary pain relief and increased local blood circulation in patients requiring dental soft tissue management or muscle/joint pain relief.

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

SIROLaser Blue (K180044)
SIROLaser Advance+ (K170500)

Reference Devices

SIROLaser Advance (K103753)
Epic Pro (K163128)
IQ 630-670 (K071687)
ACL-5500 (K930210)

Submission Summary (Full Text)

{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 and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. March 10, 2022 Guilin Woodpecker Medical Instrument Co., Ltd. % Fu Ailing Consultant Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square, Liuxian Avenue, Xili Town, Nanshan District Shenzhen, Guangdong 518055 China Re: K210367 Trade/Device Name: D-Laser Blue, D-Laser 16 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, ILY, GEX Dated: January 11, 2022 Received: January 11, 2022 Dear Fu Ailing: 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. For 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) K210367 Device Name D-Laser Blue, D-Laser 16 #### Indications for Use (Describe) D-Laser Blue and D-Laser 16 are intended for intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue including marginal and epithelial lining of free gingiva and are indicated for: frenectomy; frenotomy; implant recovery; gingivectomy; gingivectomy; gingivoplasty; gingival troughing; crown lengthening; hemostasis of donor site; removal of granulation tissue; laser assisted flap surgery; debridement of diseased epithelial lining: incisions and draining of abscesses: tissue retraction for impressions: papillectory; 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 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. Whitening: D-Laser Blue and D-Laser 16 are indicated for light activation for bleaching materials for teeth whitening and for laser-assisted whitening/bleaching of teeth. Low Level Laser Therapy: D-Laser Blue and D-Laser 16 are intended to emit energy in the red and infrared spectrum to provide topical heating for the purpose of elevating tissue temperary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, and for the temporary increase in local blood circulation and/or temporary relaxation of muscles. | 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. 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}------------------------------------------------ {4}------------------------------------------------ ### K210367 This summary of 510(K) safety and effectiveness is submitted according to requirements of SMDA and 21 CFR §807.92. ### 5.1 Administrative Information | Date of Summary prepared | November 10, 2020 | |--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer information | Submitter's Name: Guilin Woodpecker Medical Instrument Co., Ltd. Address: Information Industrial Park, Guilin National High- Tech Zone, Guilin, Guangxi, 541004, China Contact person: Yang Yunfeng TEL: +86-773-2350532 FAX: +86-773-5822450 Mail: ipr@glwoodpecker.com | | Submission Correspondent | Company Name: Shenzhen Joyantech Consulting Co., Ltd. Address: Room 1713A, 17 Floor, Block A, Zhongguan Times Square, Liuxian Avenue, Xili Town, Nanshan District, Shenzhen, Guangdong, 518055, China Contact person: Ms. Fu Ailing E-Mail: aileen@cefda.com Image: [Logo] | | Establishment registration number | 3005581016 | ### 5.2 Device Information | Type of 510(k) submission: | Traditional | |----------------------------|----------------------------------------------------------------------------------------| | Common Name: | Dental Diode Lasers | | Trade Name: | D-Laser Blue, D-Laser 16 | | Model: | D-Laser Blue, D-Laser 16 | | Classification name: | Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology | | Review Panel: | General & Plastic Surgery | | Primary Product Code: | NVK | {5}------------------------------------------------ Version:A/0 Product: D-Laser Blue, D-Laser 16 | Secondary Product Codes | GEX, ILY | |-------------------------|-----------------| | Device Class: | II | | Regulation Number: | 21 CFR 878.4810 | #### 5.3 Predicate Devices and Reference Devices | Predicate Devices | | | |-------------------|-----------------|--------------------| | Sponsor: | Dentsply Sirona | Dentsply Sirona | | Device: | SIROLaser Blue | SIROLaser Advance+ | | 510(K) Number: | K180044 | K170500 | #### Reference Devices | | Sirona Dental Systems GmbH | Biolase, Inc | Iridex Corporation | ILT Systems, Inc. | |----------------|-------------------------------|--------------|-----------------------|----------------------| | Sponsor: | | | | | | Device: | SIROLaser Advance | Epic Pro | IQ 630-670 | ACL-5500 | | 510(K) Number: | K103753 | K163128 | K071687 | K930210 | ### 5.4 Device Description The dental diode laser systems, D-Laser Blue and D-Laser 16, realize oral soft tissue surgery, periodontal disease, endodontic disease, pain treatment, soft laser therapy and other oral diseases by vaporizing, carbonizing and solidifying the tissue by laser. The device features include: Using a capacitive touch screen which has the clear display and is easy to operate; Builtin large-capacity rechargeable lithium battery with longer time of endurance; The handpiece sleeve and the fiber tip can be autoclaved to prevent from cross infection; Preset more than 20 treatment procedures to reduce the difficulty of use; A secure protection mechanism that automatically shuts down the device after 5 minutes of inactivity. The D-Laser Blue and the D-Laser 16 respectively consist of a main unit, a laser transmission system and a power adapter. The main unit includes a semiconductor laser, a power supply system and a control device, a safety protection device and a display device. {6}------------------------------------------------ Version:A/0 #### Product: D-Laser Blue, D-Laser 16 The D-Laser Blue employs the diodes with wavelengths of 976nm, 650nm and 450nm, and the device emits laser output energy in the infrared, red and blue spectra respectively. The D-Laser 16 employs the diodes with wavelengths of 976nm and 650nm, and the device emits laser output energy in the infrared, red spectra respectively. #### 5.5 Indications for Use D-Laser Blue and D-Laser 16 are intended for intra- and extra-oral surgery including incision, excision, hemostasis, coaqulation and vaporization of soft tissue including marginal and interdental and epithelial lining of free gingiva and are indicated for: 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 diseased 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 and excision; treatment of canker sores; herpetic ulcers of the oral mucosa; laser soft tissue curettage; reduction of gingival hypertrophy. Whitening: D-Laser Blue and D-Laser 16 are indicated for light activation for bleaching materials for teeth whitening and for laser-assisted whitening/bleaching of teeth. Low Level Laser Therapy: D-Laser Blue and D-Laser 16 are intended to emit energy in the red and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, and for the temporary increase in local blood circulation and/or temporary relaxation of muscles. ### 5.6 Indications for Use and Technological Characteristics of the Subject Devices Compared to the Predicate Devices {7}------------------------------------------------ | Guilin Woodpecker | 004_510(k) Summary | |-----------------------------------|--------------------| | Product: D-Laser Blue, D-Laser 16 | Version:A/0 | #### Table 1 Comparison Between the Indications for Use and Technological Characteristics of D-Laser Blue and those of the Predicate and Reference Devices | Proposed Device | Predicate Device | Reference Devices | | | | Discussion of the differences between proposed device and predicate device | |---------------------------------------------------------|--------------------------------------------------|------------------------------------------------------|--------------------------------------------------|--------------------------------------------------------------------------------|-----------------------------------------------|-------------------------------------------------------------------------------------| | Guilin Woodpecker D-Laser Blue (To be decided) | Dentsply Sirona SIROLaser Blue (K180044) | Dentsply Sirona SIROLaser Advance (K103753) | Biolase, Inc Epic Pro (K163128) | IRIDEX Corporation Iridex IQ Laser System IQ 630- 670 (K071687) | ILT Systems, Inc. ACL-5500 (K930210) | | | Product Code | | | | | | | | NVK, GEX, ILY | GEX, ILY | GEX | GEX | GEX | GEX | / | | Regulation Number | | | | | | | | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | / | | Classification | | | | | | | | Class II | Class II | Class II | Class II | Class II | Class II | / | | Surgical Indication for Use | | | | | | | | Intended for intra- | Intended for intra- | Intended for intra- | Intended for incision, | Indicated for use in | Intended for use in | | | and extra-oral | and extra-oral | and extra-oral | excision, | photocoagulation of | dental intraoral soft | | | surgery including | surgery including | surgery including | vaporization, | both anterior and | tissue, general, oral | | | incision, excision, | incision, excision, | incision, excision, | ablation, hemostasis, | posterior segments | maxilla-facial and | / | | hemostasis, | hemostasis, | hemostasis, | or coagulation of | including: | cosmetic surgery. It is | | | coagulation and | coagulation and | coagulation and | intraoral and extra- | * Retinal | intended for ablating, | | | vaporization of soft | vaporization of soft | vaporization of soft | oral soft tissue | photocoagulation, | incising, excising, | | | Proposed Device | Predicate Device | Reference Devices | | | | Discussion of the differences between proposed device and predicate device | | Guilin Woodpecker D-Laser Blue (To be decided) | Dentsply Sirona SIROLaser Blue (K180044) | Dentsply Sirona SIROLaser Advance (K103753) | Biolase, Inc Epic Pro (K163128) | IRIDEX Corporation Iridex IQ Laser System IQ 630- 670 (K071687) | ILT Systems, Inc. ACL-5500 (K930210) | | | tissue including | tissue including | tissue including | (including marginal | panretinal | aporizing and | / | | marginal and inter- | marginal and inter- | marginal and inter- | and interdental | photocoagulation | coagulation of soft | / | | dental and epithelial | dental and epithelial | dental and epithelial | gingiva and epithelial | and intravitreal | /tissues using a fiber | / | | lining of free gingiva | lining of free gingiva | lining of free gingiva | lining of free | endophotocoagulati | optic delivery system. | / | | and is indicated for: | and is indicated for: | and is indicated for: | gingiva); examples | on of vascular and | The following are the | / | | | | | include: | structural | indications for which | / | | | | | | abnormalities of the | the device will be | / | | | | | | retina and choroid | marketed: | / | | | | | | including: | | | | frenectomy; | frenectomy; | frenectomy; | frenectomy; | > proliferative and | frenectomy; | / | | frenotomy; | frenotomy; | frenotomy; | frenotomy; | nonproliferative | frenotomy; | / | | biopsy; | biopsy; | biopsy; | biopsy; | diabetic | Excision and incision | / | | operculectomy; | operculectomy; | operculectomy; | operculectomy; | retinopathy; | biopsies; | / | | | | | | > choroidal | operculectomy | / | | implant recovery; | implant recovery; | implant recovery; | implant recovery; | neovascularization; | N/A | / | | gingivectomy; | gingivectomy; | gingivectomy; | gingivectomy; | > branch retinal vein | gingivectomy; | / | | gingivoplasty; | gingivoplasty; | gingivoplasty; | gingivoplasty; | occlusion; | gingivoplasty; | / | | Proposed Device | Predicate Device | Reference Devices | | | | Discussion of the differences between proposed device and predicate device | | Guilin Woodpecker D-Laser Blue (To be decided) | Dentsply Sirona SIROLaser Blue (K180044) | Dentsply Sirona SIROLaser Advance (K103753) | Biolase, Inc Epic Pro (K163128) | IRIDEX Corporation Iridex IQ Laser System IQ 630- 670 (K071687) | ILT Systems, Inc. ACL-5500 (K930210) | | | gingival troughing; | gingival troughing; | gingival troughing; | gingival troughing; | > age-related | N/A | / | | crown lengthening; | crown lengthening; | crown lengthening; | crown lengthening; | macular degeneration | Soft tissue crown lengthening | / | | hemostasis of donor site; | hemostasis of donor site; | hemostasis of donor site; | hemostasis of donor site; | > retinal tears and detachments | Hemostatic assistance | / | | removal of granulation tissue; | removal of granulation tissue; | removal of granulation tissue; | removal of granulation tissue; | > retinopathy of prematurity | N/A | / | | laser assisted flap surgery; | laser assisted flap surgery; | laser assisted flap surgery; | laser assisted flap surgery; | * Iridotomy, iridectomy and | N/A | / | | debridement of diseased epithelial lining; | debridement of diseased epithelial lining; | debridement of diseased epithelial lining; | debridement of diseased epithelial lining; | trabeculoplasty in angle closure glaucoma and open | N/A | / | | incisions and draining of abscesses; | incisions and draining of abscesses; | incisions and draining of abscesses; | incisions and draining of abscesses; | angle glaucoma | incisions and draining of abscesses; | / | | tissue retraction for impressions; | tissue retraction for impressions; | tissue retraction for impressions; | tissue retraction for impressions; | / | tissue retraction for impressions; | / | | papillectomy; | papillectomy; | papillectomy; | papillectomy; | / | Oral papillectomy | / | | Proposed Device | Predicate Device | Reference Devices | | | | Discussion of the differences between proposed device and predicate device | | Guilin Woodpecker D-Laser Blue (To be decided) | Dentsply Sirona SIROLaser Blue (K180044) | Dentsply Sirona SIROLaser Advance (K103753) | Biolase, Inc Epic Pro (K163128) | IRIDEX Corporation Iridex IQ Laser System IQ 630- 670 (K071687) | ILT Systems, Inc. ACL-5500 (K930210) | | | vestibuloplasty; | vestibuloplasty; | vestibuloplasty; | vestibuloplasty; | | N/A | / | | excision of lesions; | excision of lesions; | excision of lesions; | excision of lesions; | | N/A | / | | exposure of | exposure of | exposure of | exposure of | | N/A | / | | unerupted/partially erupted teeth; | unerupted/partially erupted teeth; | unerupted/partially erupted teeth; | unerupted/partially erupted teeth; | | N/A | / | | removal of hyperplastic tissues; | removal of hyperplastic tissues; | removal of hyperplastic tissues; | removal of hyperplastic tissues; | | N/A | / | | treatment of aphthous ulcers; | treatment of aphthous ulcers; | treatment of aphthous ulcers; | treatment of aphthous ulcers; | | treatment of aphthous ulcers; | / | | leukoplakia; | leukoplakia; | leukoplakia; | leukoplakia; | | N/A | / | | pulpotomy; | pulpotomy; | pulpotomy; | pulpotomy; | | N/A | / | | pulpotomy as adjunct to root canal therapy; | pulpotomy as adjunct to root canal therapy; | pulpotomy as adjunct to root canal therapy; | pulpotomy as adjunct to root canal therapy; | | N/A | / | | fibroma removal; | fibroma removal; | fibroma removal; | N/A | | Removal of fibromas; | / | | gingival incision and excision; | gingival incision and excision; | gingival incision and excision; | N/A | | gingival incision and excision; | / | {8}------------------------------------------------ 004_510(k) Summary Version:A/0 {9}------------------------------------------------ 004_510(k) Summary Version:A/0 {10}------------------------------------------------ 004_510(k) Summary Version:A/0 {11}------------------------------------------------ Reference Devices IRIDEX Corporation Iridex IQ Laser System IQ 630- 670 (K071687) Biolase, Inc Epic Pro (K163128) N/A N/A N/A | reduction of gingival hypertrophy. | reduction of gingival hypertrophy. | |---------------------------------------|---------------------------------------| | Indications for Use | | Predicate Device Dentsply Sirona SIROLaser Blue (K180044) treatment of canker sores; herpetic ulcers of the oral mucosa; laser soft tissue curettage; Dentsply Sirona SIROLaser Advance (K103753) treatment of canker of the oral mucosa; laser soft tissue curettage; sores; herpetic ulcers | Laser Periodontic Indications for Use | | | | | | | |-----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|-----|------------------------------------------------------------------|---| | laser removal of diseased, infected, inflamed and necrosed soft tissue; within the periodontal pocket; | laser removal of diseased, infected, inflamed and necrosed soft tissue; within the periodontal pocket; | laser removal of diseased, infected, inflamed and necrosed soft tissue; within the periodontal pocket; | N/A | N/A | N/A | / | | sulcular debridement (removal of diseased, infected, inflamed | sulcular debridement (removal of diseased, infected, inflamed | sulcular debridement (removal of diseased, infected, inflamed | sulcular debridement (removal of diseased or inflamed soft tissu | N/A | Sulcular debridement (removal of diseased or inflamed soft | / | Product: D-Laser Blue, D-Laser 16 Guilin Woodpecker Proposed Device Guilin Woodpecker D-Laser Blue (To be decided) treatment of canker sores; herpetic ulcers of the oral mucosa; reduction of gingival laser soft tissue curettage; hypertrophy. Version:A/0 Discussion of the differences between proposed device and predicate device #### 004_510(k) Summary / / ILT Systems, Inc. ACL-5500 (K930210) N/A N/A N/A {12}------------------------------------------------ 004_510(k) Summary Version:A/0 | Proposed Device | Predicate Device | Reference Devices | | | Discussion of the differences between proposed device and predicate device | | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|--------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------| | Guilin Woodpecker D-Laser Blue (To be decided) | Dentsply Sirona SIROLaser Blue (K180044) | Dentsply Sirona SIROLaser Advance (K103753) | Biolase, Inc Epic Pro (K163128) | IRIDEX Corporation Iridex IQ Laser System IQ 630- 670 (K071687) | ILT Systems, Inc. ACL-5500 (K930210) | | | 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); | 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); | 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); | e in the periodontal p ocket) | N/A | tissue in the periodontal pocket); Photo initiation of gingival barriers and dams | | | Tooth Whitening Indications for Use | | | | | | | | Light activation for bleaching materials for teeth whitening. laser-assisted whitening/bleaching of teeth. | Light activation for bleaching materials for teeth whitening. laser-assisted whitening/bleaching of teeth. | N/A | Light activation for bleaching materials for teeth whitening. | N/A | Laser-assisted bleaching/whitening of teeth | / | | Proposed Device | Predicate Device | Reference Devices | | | | Discussion of the differences between proposed device and predicate device | | Guilin Woodpecker D-Laser Blue (To be decided) | Dentsply Sirona SIROLaser Blue (K180044) | Dentsply Sirona SIROLaser Advance (K103753) | Biolase, Inc Epic Pro (K163128) | IRIDEX Corporation Iridex IQ Laser System IQ 630- 670 (K071687) | ILT Systems, Inc. ACL-5500 (K930210) | | | Low Level Laser Therapy Indications for Use | | | | | | | | Intended to emit energy in the red and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, and for the temporary increase in local blood circulation | Intended to emit energy in the red and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, and for the temporary increase in local blood circulation | N/A | N/A | N/A | N/A | / | {13}------------------------------------------------ Product: D-Laser Blue, D-Laser 16 Version:A/0 {14}------------------------------------------------ | Product: D-Laser Blue. D-Laser 16 | |-----------------------------------| Guilin Woodpecker 004_510(k) Summary Version:A/0 | Proposed Device | Predicate Device | Reference Devices | | | | Discussion of the differences between proposed device and predicate device | |----------------------------------------------------------------------|-----------------------------------------------------------------------|--------------------------------------------------------------------------|---------------------------------------------|--------------------------------------------------------------------------------|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Guilin Woodpecker D-Laser Blue (To be decided) | Dentsply Sirona SIROLaser Blue (K180044) | Dentsply Sirona SIROLaser Advance (K103753) | Biolase, Inc Epic Pro (K163128) | IRIDEX Corporation Iridex IQ Laser System IQ 630- 670 (K071687) | ILT Systems, Inc. ACL-5500 (K930210) | | | and/or temporary | and/or temporary | | | | | | | relaxation of muscles. | relaxation of muscles. | | | | | | | Application | | | | | | | | Dental Laser | Dental Laser | Dental Laser | Dental Laser | IQ Laser | Curing Laser | / | | Laser Classification | | | | | | | | 976 nm and 450nm Laser: Class IV 650 nm Laser: Class II | 970 nm and 445 nm Laser: Class IV 660 nm Laser: Class II | 970 nm: Class IV | 980 nm: Class IV | 630-670 nm | 450 nm | According to K180044, K103753 and K163128, the upper limit is 980 nm, the low limit is 970 nm, so 976 nm can be accepted. According to K930210, 450 nm can be accepted. According to K071687, 650 nm can be accepted. | | Laser Type | | | | | | | | Solid state diode | Solid state diode | Solid state diode | Solid state diode | Diode, Diode- | Argon Ion | / | | Proposed Device | Predicate Device | Reference Devices | | | | Discussion of the differences between proposed device and predicate device | | Guilin Woodpecker D-Laser Blue (To be decided) | Dentsply Sirona SIROLaser Blue (K180044) | Dentsply Sirona SIROLaser Advance (K103753) | Biolase, Inc Epic Pro (K163128) | IRIDEX Corporation Iridex IQ Laser System IQ 630- 670 (K071687) | ILT Systems, Inc. ACL-5500 (K930210) | | | | | | | pumped, | | | | | | | | frequency doubled, | | | | | | | | solid state | | | | Laser Wavelength | | | | | | | | 976 nm (+/-20 nm) | 970 nm (-10/+15 nm) | 970 nm (+/-15 nm) | 980 nm (+/-20 nm) | 630-670 nm | 450 nm (+/-20 nm) | According to K103753, the | | (956-996) | (960-985) | (955-985) | (960-1000) | | (430-470) | lowest value 955 nm can be | | | | | | | | accepted. According to | | | | | | | | K163128, the highest value | | | | | | | | 1000 can be accepted. As a | | | | | | | | result, 956-996 nm can be | | | | | | | | accepted. | | 650 nm (+/-20 nm) | 660 nm (+/-5 nm) | | | | | According to K071687, 630- | | (630-670) | (655-665) | | | | | 670 nm can be accepted. | | 450 nm (+/-20 nm) | 445 nm (+/-5 nm) | | | | | According to K930210, 430- | | (430-470) | (440-450) | | | | | 470 nm can be accepted. | | Optical Power | | | | | | | | 976 nm: | 970 nm: | 970 nm: | 980 nm: | 630-670 nm: | 450 nm: | According to K163128, the | | Proposed Device | Predicate Device | Reference Devices | | | | Discussion of the differences between proposed device and predicate device | | Guilin Woodpecker D-Laser Blue (To be decided) | Dentsply Sirona SIROLaser Blue (K180044) | Dentsply Sirona SIROLaser Advance (K103753) | Biolase, Inc Epic Pro (K163128) | IRIDEX Corporation Iridex IQ Laser System IQ 630- 670 (K071687) | ILT Systems, Inc. ACL-5500 (K930210) | | | 0.2 W - 4 W (Continuous Wave) 7 W (peak power) | 0.2 W - 2.0 W (Continuous Wave) | 7.0 W max. (Continuous Wave) 14 W (peak optical power) | 0.2 W - 25 W | ≤ 5W | 500 mW | highest value 25W can be accepted, so 0.2 W - 4 W can be accepted. | | 650 nm: 25 mW-200 mW (Continuous Wave) | 660 nm: 25 mW, 50 mW, 100 mW (Continuous Wave) | | |…

D-Laser Blue, D-Laser 16

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

D-Laser Blue, D-Laser 16

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Create Alert

Search Filters

Agent Token

Connected apps

Welcome

Check your email

Welcome!