← Product Code [NVK](/submissions/SU/subpart-e%E2%80%94surgical-devices/NVK) · K210367
# D-Laser Blue, D-Laser 16 (K210367)
_Guilin Woodpecker Medical Instrument Co., Ltd. · NVK · Mar 10, 2022 · General, Plastic Surgery · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/NVK/K210367
## Device Facts
- **Applicant:** Guilin Woodpecker Medical Instrument Co., Ltd.
- **Product Code:** [NVK](/submissions/SU/subpart-e%E2%80%94surgical-devices/NVK.md)
- **Decision Date:** Mar 10, 2022
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4810
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery
- **Attributes:** Therapeutic
## Intended 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.
## 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
- SIROLaser Blue ([K180044](/device/K180044.md))
- SIROLaser Advance+ ([K170500](/device/K170500.md))
## Reference Devices
- SIROLaser Advance ([K103753](/device/K103753.md))
- Epic Pro ([K163128](/device/K163128.md))
- IQ 630-670 ([K071687](/device/K071687.md))
- ACL-5500 ([K930210](/device/K930210.md))
## Submission Summary (Full Text)
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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.
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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.
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
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### 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) |
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### 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 |
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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.
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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
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| 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; | / |
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004_510(k) Summary
Version:A/0
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004_510(k) Summary
Version:A/0
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004_510(k) Summary
Version:A/0
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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) | | |…
---
**Source:** [https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/NVK/K210367](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/NVK/K210367)
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