(423 days)
No
The summary describes a standard diode laser system with microprocessor control and user-friendly interface, but there is no mention of AI or ML capabilities in the intended use, device description, or performance studies.
Yes
The "Intended Use / Indications for Use" section explicitly states therapeutic applications such as incision, excision, hemostasis, coagulation, vaporization of soft tissue, treatment of pain, and muscle spasm relief.
No
The provided text describes the Medical Diode Laser System's intended use for various surgical procedures, teeth whitening, and low-level laser therapy, all of which are therapeutic or cosmetic applications. There is no mention of the device being used to diagnose a medical condition or disease.
No
The device description clearly outlines hardware components such as a power supply, microprocessor, LCD screen, high power lasers, Lithium battery, and GaAlAs semiconductor material diodes. It is a physical laser system, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes surgical procedures performed directly on soft tissue (incision, excision, hemostasis, coagulation, vaporization), teeth whitening, and low-level laser therapy for pain relief and circulation. These are all direct treatments applied to the patient's body.
- Device Description: The device description details a laser system that emits light for therapeutic purposes. It does not mention any components or processes related to analyzing samples taken from the body (like blood, urine, tissue biopsies, etc.).
- Lack of IVD Characteristics: IVD devices are designed to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis.
The device is a therapeutic laser system used for various dental and medical procedures, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Medical Diode Laser Systems 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; biopsy; operculectomy; implant recovery; gingivoplasty; 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;papillectorny; 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: Medical Diode Laser Systems are indicated for light activation materials for teeth whitening and for laser-assisted whitening/bleaching of teeth.
Low Level Laser Therapy: Medical Diode Laser Systems are intended to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffins pain, or muscle spasm, and for the temporary increase in local blood circulation and/or temporary relaxation of muscles.
Product codes (comma separated list FDA assigned to the subject device)
NVL, GEX, ILY, EEG
Device Description
The Medical Diode Laser System is a compact, air-cooled unit. It is a complete self-contained instrument, which includes a high efficiency power supply, a microprocessor controlled, adjustable light output with automatic power stabilization, (fan cooled), as well as a switch panel and LCD screen display panel designed to be user friendly. The system includes high power lasers, safety features and an SMA fiber output connector. The system includes a Lithium battery, it can work 1hour when not external power input at maximum power output in pulse or CW but intermittent mode. The diodes are made from GaAlAs semiconductor material for high output and superior reliability. The diode lasers are enclosed in a rugged, factory-aligned, replaceable, environmentally protective module. High-capacity fans eliminate the need for water-cooling, and assure low maintenance and reliable laser operation. The diodes convert electric energy into coherent laser radiation with a wavelength of 810nm or 980nm+/-10nm (pilot beam: 650nm+/-10nm).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intra- and extra-oral soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Electrical safety and electromagnetic compatibility (EMC) testing were conducted on the Medical Diode Laser System.
- Verify the conformity of the proposed devices with the requirements of IEC 60601-1:(Medical electrical equipment Part 1: General requirements for basic safety and essential performance).
- Verify the conformity of the proposed devices with the requirements of IEC 60601-1-2:(Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral Standard: Electromagnetic compatibility).
- Verify the conformity of the proposed devices to IEC 60825-1 (Safety of laser products - Part 1: Equipment classification and requirements).
- Verify the performance of the proposed devices according to IEC 60601-2-22: -(Medical electrical equipment Part 2: Particular Requirements for basic safety and essential performance of surgical, cosmetic, therapeutic, and diagnostic laser equipment).
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
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 and 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.
March 4, 2024
Gigaalaser Company Ltd. Xinxing Nie Regulations Control Manager 304, 306, 3F No.3 plant, Building B10 Wuhan Hi-Tech Medical Device Industrial Park Wuhan, Hubei 430206 CHINA
Re: K230047
Trade/Device Name: Medical Diode Laser Systems 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: NVL, GEX, ILY, EEG Dated: February 2, 2024 Received: February 2, 2024
Dear Xinxing Nie:
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 (the 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 available 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
2
Sincerely,
Michael E. Adjodha -S
Michael E. Adjodha, MChE, RAC, CQIA 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
3
Indications for Use
510(k) Number (if known) K230047
Device Name Medical Diode Laser Systems
Indications for Use (Describe)
Medical Diode Laser Systems 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; biopsy; operculectomy; implant recovery; gingivoplasty; 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;papillectorny; 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: Medical Diode Laser Systems are indicated for light activation materials for teeth whitening and for laser-assisted whitening/bleaching of teeth.
Low Level Laser Therapy: Medical Diode Laser Systems are intended to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffins 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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | ☑ |
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
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4
Section 5 510(k) summary
l Submitter
- Device submitter: Gigaalaser Company Ltd. Add.: 304, 306, 3F No.3 plant, Building B10, Wuhan Hi-Tech Medical Device Industrial Park, #818 Gaoxin Avenue, East Lake Development Zone, Wuhan,China (Free Trade Zone Wuhan Area)
- Contact person: Xinxing Nie Title: Regulations Control Manager Phone: +86-27-18086025718 Fax: +86-27-6784 8873 Email: fdagigaalaser@sohu.com
II Device
| Trade Name of Device: | Medical Diode Laser Systems |
|---|---|
| Common name: | Dental diode laser |
| Classification name: | Laser Surgical Instrument for Use in General and |
| Plastic Surgery and in Dermatology | |
| Classification: | Class II, 21 CFR 878.4810 |
| Primary Product Code: | NVK |
| Secondary Product Codes: | GEX, ILY |
| Review Panel: | General & Plastic Surgery |
| Submission number: | Unknown |
III Predicate Device and Reference Device
| Primary Predicate Device | |
|---|---|
| Trade name: | D-Laser Blue, D-Laser 16 |
| Common name: | Dental Diode Lasers |
| Regulation number: | 21 CFR 878.4810 |
| Classification | Laser Surgical Instrument for Use in General and Plastic Surgery |
| Name: | and in Dermatology |
| Requlatory class: | Class II |
| Product code: | NVK, GEX, ILY |
| Submitter: | Guilin Woodpecker Medical Instrument Co., Ltd. |
| 510(k) number: | K210367 |
Reference Predicate Device Gemini 810+980 Diode Laser Trade name:
5
| Common name: | Powered laser surgical instrument, Infrared lamp |
|---|---|
| Regulation number: | 21 CFR 878.4810 |
| Classification | |
| Name: | Laser Surgical Instrument for Use in General and Plastic Surgery |
| and in Dermatology; and infrared lamp | |
| Regulatory class: | Class II |
| Product code: | GEX, ILY |
| Submitter: | Azena Medical, LLC |
| 510(k) number: | K192617 |
IV Device description
The Medical Diode Laser System is a compact, air-cooled unit. It is a complete self-contained instrument, which includes a high efficiency power supply, a microprocessor controlled, adjustable light output with automatic power stabilization, (fan cooled), as well as a switch panel and LCD screen display panel designed to be user friendly. The system includes high power lasers, safety features and an SMA fiber output connector. The system includes a Lithium battery, it can work 1hour when not external power input at maximum power output in pulse or CW but intermittent mode. The diodes are made from GaAlAs semiconductor material for high output and superior reliability. The diode lasers are enclosed in a rugged, factory-aligned, replaceable, environmentally protective module. High-capacity fans eliminate the need for water-cooling, and assure low maintenance and reliable laser operation. The diodes convert electric energy into coherent laser radiation with a wavelength of 810nm or 980nm+/-10nm (pilot beam: 650nm+/-10nm).
| Product | Model | Output power | Laser Wavelength |
|---|---|---|---|
| Medical | |||
| Diode Laser | |||
| Systems | DEN7A | 0.1W-7W (±20%) | 810nm±10nm |
| DEN7B | 0.1W-7W (±20%) | 980nm±10nm | |
| DEN10B | 0.1W-10W (±20%) | 980nm±10nm | |
| CHEESEII-7A | 0.1W-7W (±20%) | 810nm±10nm | |
| CHEESEII-7B | 0.1W-7W (±20%) | 980nm±10nm | |
| CHEESEII-10B | 0.1W-10W (±20%) | 980nm±10nm | |
| GBOX-20B | 1-20W (±10%) | 980nm±10nm | |
| GBOX-15A | 1-15W (±10%) | 810nm±10nm | |
| GBOX-15B | 1-15W (±10%) | 980nm±10nm | |
| GBOX-15AB | 810nm/980nm: 1-15W | ||
| (±10%) | 810nm±10nm | ||
| 980nm±10nm | |||
| 810nm+980nm: 1W-15W | 810nm+980nm(±10nm) |
The product is divided into 10 models according to wavelength and output power:
6
| (±10%) | ||||
|---|---|---|---|---|
| -- | -- | -------- | -- | -- |
V Indications for use
Medical Diode Laser Systems are intended for intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue including marginal and inter-dental 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; papillectorny; vestibuloplasty ; excision of lesions; exposure of unerupted/partially erupted teeth; removal of hyperplastic tissues; treatment of aphthous ulcers; leukoplakia; laser removal of diseased, infected, 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: Medical Diode Laser Systems are indicated for light activation for bleaching materials for teeth whitening and for laser-assisted whitening/bleaching of teeth.
Low Level Laser Therapy: Medical Diode Laser Systems are intended 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.
7
VI Comparison of technological characteristics with the predicate devices
The Medical Diode Laser System has the same intended use and principal operation, the technology, design and performance specifications are either identical or substantially equivalent to existing legally marketed predicate devices. The differences between the Medical Diode Laser System and predicate devices do not alter suitability of the proposed device for its intended use.
| Item | Proposed device | Predicate device
(K210367) | Reference device
(K192617) | Discussion |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product
Code | Medical Diode Laser Systems
NVK, GEX, ILY | D-Laser Blue, D-Laser 16
NVK, GEX, ILY | Gemini 810+980 Diode Laser
GEX, ILY | Identical |
| Regulation
Number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Identical |
| Classificati
on | Class II | Class II | Class II | Identical |
| Indication
for Use | Medical Diode Laser Systems are
intended for intra- and extra-oral
surgery including incision, excision,
hemostasis, coagulation and
vaporization of soft tissue including
marginal and inter-dental 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 | 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 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 | 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 | Substantial
Equivalence
The
reference
device does
not have the
intended use
for light
activation for
bleaching
materials for
teeth |
| Item | Proposed device | Predicate device
(K210367) | Reference device
(K192617) | Discussion |
| | Medical Diode Laser Systems | D-Laser Blue, D-Laser 16 | Gemini 810+980 Diode Laser | |
| | 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, 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 inability); pulpotomy;
pulpotomy as adjunct to root canal
therapy; fibroma removal; gingival | 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, 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 inability);
pulpotomy; pulpotomy as adjunct to
root canal therapy; fibroma removal;
gingival incision and excision; | impressions
• Gingivectomy
• Gingivoplasty
• Gingival incision and excision
• Hemostasis and coagulation
• Implant recovery
• Incision and drainage of abscess
• Leukoplakia
• Operculectomy
• Oral papillectomies
• Pulpotomy
• Pulpotomy as an adjunct to root
canal therapy
• Reduction of gingival hypertrophy
• Soft tissue crown lengthening
• Treatment of canker sores,
herpetic and aphthous ulcers of the
oral mucosa
• Treatment of aphthous ulcers.
• Vestibuloplasty
• Tissue retraction for impression
• Lesion (tumor) removal
Laser Periodontal Procedures | whitening
and
for
laser-assiste
d
whitening/ble
aching of
teeth. While
the intended
use of
proposed
device is
same as the
predicated
device
(K210367),
this
difference
does not
affect the
safety and
effectiveness. |
| Item | Proposed device | Predicate device
(K210367) | Reference device
(K192617) | Discussion |
| | Medical Diode Laser Systems | D-Laser Blue, D-Laser 16 | Gemini 810+980 Diode Laser | |
| | incision and excision; treatment of
canker sores; herpetic ulcers of the
oral mucosa; laser soft tissue
curettage; reduction of gingival
hypertrophy. | treatment of canker sores; herpetic
ulcers of the oral mucosa; laser soft
tissue curettage; reduction of gingival
hypertrophy. | • Laser soft tissue curettage.
• Laser removal of diseased,
Infected, Inflamed and necrosed soft
tissue within the periodontal pocket.
• Removal of highly inflamed
edematous tissue affected by
bacteria penetration of the pocket
lining and junctional epithelium.
• 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)
• Reduction of bacterial level
(decontamination) and inflammation | |
| | Whitening: Medical Diode Laser
Systems are indicated for light
activation for bleaching materials for
teeth whitening and for laser-assisted
whitening/bleaching of teeth. | 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. | NA | |
| | Low Level Laser Therapy: Medical | Low Level Laser Therapy: D-Laser | Pain therapy: | |
| Item | Proposed device | Predicate device
(K210367) | Reference device
(K192617) | Discussion |
| | Medical Diode Laser Systems | D-Laser Blue, D-Laser 16 | Gemini 810+980 Diode Laser | |
| | Diode Laser Systems are intended 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. | 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. | • 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. | |
| Application | Dental Laser | Dental Laser | Dental Laser | Identical |
| Laser
Classification | Class IV | 976 nm and 450nm: Laser: Class IV
650 nm Laser: Class II | Class IV | Substantial
Equivalence |
| Type of
Laser | Diode Laser | Diode Laser | Diode Laser | Identical |
| Wavelength | 810 ± 10nm;
980 ± 10nm; | 976 nm (+/-20 nm);
650 nm (+/-20 nm);
450 nm (+/-20 nm); | 810 ± 10nm;
or 980 ± 10nm;
or 810nm and 980nm ± 10nm | Substantial
Equivalence
According to
K192617, the
modification |
| Item | Proposed device | Predicate device
(K210367) | Reference device
(K192617) | Discussion |
| | Medical Diode Laser Systems | D-Laser Blue, D-Laser 16 | Gemini 810+980 Diode Laser | |
| | | | | does not
adversely
affect safety
and
effectiveness |
| Average
Power | DEN7A/DEN7B: 0.1W-7W;
DEN10B: 0.1W-10W; | D-Laser Blue 976nm:
0.2 W – 4 W (Continuous Wave)
7 W (peak power);
D-Laser 16 976nm: | 0.1-2W; 20W (peak power) | Similar as the
predate
device. |
| | | 0.3 W - 7 W (Continuous Wave)
16 W (peak power); | | |
| | CHEESEII-7A/7B: 0.1W-7W;
CHEESEII-10B: 0.1W-10W; | D-Laser Blue 976nm:
0.2 W – 4 W (Continuous Wave)
7 W (peak power);
D-Laser 16 976nm: | 0.1-2W; 20W (peak power) | Similar as the
predate
device. |
| | | 0.3 W - 7 W (Continuous Wave)
16 W (peak power); | | |
| | GBOX-20B: 1-20W;
GBOX-15A/15B: 1-15W; | D-Laser Blue 976nm:
0.2 W – 4 W (Continuous Wave) | 0.1-2W; 20W (peak power) | Similar as the
reference |
| | GBOX-15AB: 1-15W. | 7 W (peak power);
D-Laser 16 976nm: | | device |
| Item | Proposed device | Predicate device
(K210367) | Reference device
(K192617) | Discussion |
| | Medical Diode Laser Systems | D-Laser Blue, D-Laser 16 | Gemini 810+980 Diode Laser | |
| | | 0.3 W - 7 W (Continuous Wave) | | |
| | | 16 W (peak power); | | |
| Operation | Continuous Wave; Pulse | Continuous Wave; Pulse | Pulse | Identical to |
| Mode | | | | the predicate |
| Pulse | DEN7A/ DEN7B/DEN10B: | 5 µsec. To 0.9 sec. | Variable | Similar |
| width | 1ms-1000ms; | | | |
| | CHEESEII-7A/7B/10B: 25µs -10s | | | |
| | GBOX-15A/ 15B/ 15AB/20B: 25µs | | | |
| | -10s | | | |
| Pulse | DEN7A/ DEN7B/DEN10B: | 1 Hz — 20 kHz | 50Hz | Similar |
| repetition | 0.5Hz-500Hz | | | |
| rate | CHEESEII-7A/7B/10B: 0.05Hz-20 | | | |
| | KHz | | | |
| | GBOX-15A/ 15B/ 20B: 0.05Hz-20 | | | |
| | KHz | | | |
| | GBOX-15AB: 1Hz-20 KHz | | | |
| Aiming | 650±10 nm, 5mw (max) | 650±20 nm, Pmax