(139 days)
No
The device description and the lack of mentions of AI/ML, image processing, training/test sets, or performance metrics typically associated with AI/ML algorithms indicate that this is a standard laser device without AI/ML capabilities.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is used for various medical procedures such as excision, ablation, vaporization, and photocoagulation of tissues, which are therapeutic interventions.
No.
The device is a laser indicated for therapeutic procedures like excision, ablation, vaporization, and photocoagulation of skin lesions and soft tissues. It does not mention any diagnostic capabilities.
No
The device description explicitly states it is a "medical grade, solidstate, infrared diode laser" and describes hardware components like a touch screen display, manual emergency stop button, and master key switch. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside the body.
- Device Description and Intended Use: The description of the DC 7 laser clearly indicates it is a surgical laser used for direct treatment of tissues on or within the body (excision, ablation, vaporization, photocoagulation). It is used for procedures like removing skin lesions, cutting tissue, and treating vascular lesions.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, using reagents, or providing diagnostic information based on laboratory tests.
Therefore, the DC 7 laser is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The DC 7 laser and accessories are indicated for General Surgery, Dermatology & Plastic Surgery, and Podiatry: Excision, ablation, vaporization, and photocoagulation of skin lesions, hemostasis, incision, excision, vaporization, ablation, and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissue, and dermabrasion, such as:
Matrixectomy
Excision of neuromas
Excision of periungual and subungual warts
Excision of plantar warts
Excision of Keloids
Excision of cutaneous lesions
Photocoagulation of telangiectasia, venulectasia of the legs and face
Superficial benign vascular lesions including Telangiectasias, hemangioma, Port wine stains, angiokeratoma, and benign epidermal pigment lesions as lentigines. Epidermal nevi, spider nevi
Product codes
GEX
Device Description
The DC International, LLC DC 7 is a medical grade, solidstate, infrared diode lasers (AlGaAs). The lasers are designed to deliver continuous or pulsed laser energy with a wavelength at 980 nm. The touch screen display consists of a user interactive screens that allows selection of continuous, pulsed and the, repetition rates, aiming beam on/off, procedural information display keys, a Standby/Ready key, the manual emergency stop button and the master key switch.
THE LASER SYSTEM: The laser system consists of a laser diode optical deck, cooling system, voltage power supply and system control electronics that include the touch screen control panel.
THE MAIN CONSOLE: Contains the major electrical components
DELIVERY SYSTEM: The DC 7 is delivered with fibers, handpieces and tips Safety glasses/goggles and a safety sign are also provided with the systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skin lesions, abdominal, rectal, skin, fat or muscle tissue, legs and face
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)
Non clinical Performance Data: None
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
China Daheng Group Inc DenLase (K102669), Biolase Technology Inc Diolase (K121327)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) SUMMARY
Title:
DC 7
-
Submitter: DC International, LLC David Boëgler 317-730-4601 DC International, LLC 624 Cypress Green Cir. Wellington, FL 33414
NOV 0 7 2013 -
David Boëgler Contact: 317-730-4601 DC International, LLC 624 Cypress Green Cir. Wellington, FL 33414
-
Date Prepared: June 2, 2013
Device Trade Name: DC 7
Common Name: Diode Laser Therapy System
- Classification Name: Instrument, surgical, powered laser GEX 21 CFR 878.4810
- China Daheng Group Inc DenLase (K102669), Biolase Technology Predicate Devices: Inc Diolase (K121327)
Device Description:
The DC International, LLC DC 7 is a medical grade, solidstate, infrared diode lasers (AlGaAs). The lasers are designed to deliver continuous or pulsed laser energy with a wavelength at 980 nm. The touch screen display consists of a user interactive screens that allows selection of continuous, pulsed and the, repetition rates, aiming beam on/off, procedural information display keys, a Standby/Ready key, the manual emergency stop button and the master key switch.
1
THE LASER SYSTEM: The laser system consists of a laser diode optical deck, cooling system, voltage power supply and system control electronics that include the touch screen control panel.
THE MAIN CONSOLE: Contains the major electrical components
r
DELIVERY SYSTEM: The DC 7 is delivered with fibers, handpieces and tips Safety glasses/goggles and a safety sign are also provided with the systems.
2
| | DC International, LLC
DC.7 | |
|-----------------------------------|-----------------------------------------------------------------------------------------------|--|
| Regulation: | 21CFR878.4810 | |
| Category of Device: | Prescription Device | |
| Laser Medium: | Diode Laser (GaAIAs) | |
| Wavelength: | 980 nm | |
| Power to Tissue: | DC 7: Up to 7 Watts | |
| Laser Class | Class IV | |
| Operating Modes: | Continuous, Pulsed | |
| Pulse Width: | 50us - 30s Up to 100 Hertz | |
| Beam Delivery: | Fibers, handpieces and tips | |
| Aiming Beam: | 650 nm @ 1.0 mW Max adjustable | |
| Contacting Material | Stainless steel, polypropylene and quartz | |
| Contacting Components | Hanpieces, tips and fiber | |
| Control System | Microprocessor | |
| Laser Operation: | Footswitch | |
| Electrical Supply: | 100-230 VAC, 50-60 Hz | |
| Cooling: | Internal | |
| Weight: | 3 Pounds | |
| Accessories: | Fiber, disposable tips, handpieces | |
| Software Validation: | Comply with the FDA Guidance for traditional 510(k) | |
| Electrical Safety: | Comply with IEC60601-1 | |
| Electromagnetic
Compatibility: | Comply with IEC60601-1-2 | |
| Labeling: | Comply with the related standards and refer to Labeling
documentation of 510(k) submission | |
3 of 6
.
:
3
Intended Use:
The DC 7 laser and accessories are indicated for General Surgery, Dermatology & Plastic Surgery, and Podiatry: Excision, ablation, vaporization, and photocoagulation of skin lesions, hemostasis, incision, excision, vaporization, ablation, and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissue, and dermabrasion, such as:
Matrixectomy
Excision of neuromas
Excision of periungual and subungual warts
Excision of plantar warts
Excision of Keloids
Excision of cutaneous lesions
Photocoagulation of telangiectasia, venulectasia of the legs and face
Superficial benign vascular lesions including Telangiectasias, hemangioma, Port wine stains, angiokeratoma, and benign epidermal pigment lesions as lentigines. Epidermal nevi, spider nevi
Comparison: The DC 7 has the exact technological characteristics, design, material, components, energy source as the China Daheng Group DenLase 980/7 (K102669) and it is similar to the Biolase Technology Diolase 10S, the safety and effectiveness of the DC 7 (K121327) is based upon a determination of the substantial equivalence as well as the safety and effectiveness of the medical devices.
4 of 6
4
| Company/
Specifications | DC International, LLC
DC 7 | China Daheng Group Inc
Denlase 980/7 | Biolase, Inc
Diolase 10S |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Concurrence:
510(k) Number: | K131839 | K102669 | K121327 |
| Regulation: | 21CFR878.4810 | 21CFR878.4810 | 21CFR878.4810 |
| Category of Device: | Prescription Device | Prescription Device | Prescription Device |
| Laser Medium: | Diode Laser (GaAIAs) | Diode Laser (GaAIAs) | Diode Laser (GaAIAs) |
| Wavelength: | 980 nm | 980 nm | 940 +/- 15 nm |
| Power to Tissue: | DC 7: Up to 7 Watts | DenLase 7: Up to 7 Watts | Diolase 10S: Up to 10 Watts |
| Laser Class | Class IV | Class IV | Class IV |
| Comparison
Analysis: | The maximum power output of proposed device is between that of the two predicates devices,
and all of them comply with IEC 60825-1 and IEC 60601-2-22. So the difference will not
affect the safety and effectiveness of the proposed device. | | |
| Operating Modes: | Continuous, Pulsed | Continuous, Pulsed | Continuous, Pulsed |
| Pulse Width: | 50us - 30s Up to 100 Hertz | 50us - 30s Up to 100 Hertz | |
| The pulse duration of laser should be shorter than thermal relax time of target tissues so that the thermal diffusion will
not act on the surrounding tissues during the heating process of the target tissues, in this way the surrounding tissues
can be protected. The comparatively short pulse duration of DC7 will not introduce any problems regarding the safety
and effectiveness of the device. In addition, the shorter pulse duration will decrease the injury which the laser beam
bring to the normal tissue, at the same time the shorter pulse duration will reduce the smoke caused by treatment, then
correspondingly optimize the vision during the treatment also. Considering the pulse duration range of the proposed
product include the pulse duration range of the predicated product, the difference will not introduce any problems
regarding the safety and effectiveness of the device. | | | |
| Beam Delivery: | Fibers, handpieces and tips | Fibers, handpieces and tips | Fibers, handpieces and tips |
| Aiming Beam: | 650 nm @ 1.0 mW Max
adjustable | 650 nm @ 1.0 mW Max
adjustable | 650 nm @ 1.0 mW Max
adjustable |
| Contacting Material | Stainless steel,
polypropylene and quartz | Stainless steel, polypropylene
and quartz | Stainless steel, polypropylene
and quartz |
| Contacting
Components | Hanpieces, tips and fiber | Hanpieces, tips and fiber | Hanpieces, tips and fiber |
| Control System | Microprocessor | Microprocessor | Microprocessor |
| Laser Operation: | Footswitch | Footswitch | Footswitch |
| Electrical Supply: | 100-230 VAC, 50-60 Hz | 100-230 VAC, 50-60 Hz | 100-230 VAC, 50-60 Hz |
| Cooling: | Internal | Internal | Internal |
| Weight: | 3 Pounds | 3 Pounds | 3 Pounds |
| Accessories: | Fiber, disposable tips,
handpieces | Fiber, disposable tips,
handpieces | Fiber, disposable tips,
handpieces |
| Software
Validation: | Comply with the FDA
Guidance for traditional
510(k) | Comply with the FDA
Guidance for traditional
510(k) | Comply with the FDA
Guidance for traditional
510(k) |
| Electrical Safety: | Comply with IEC60601-1 | Comply with IEC60601-1 | Comply with IEC60601-1 |
| Electromagnetic
Compatibility: | Comply with IEC60601-1-2 | Comply with IEC60601-1-2 | Comply with IEC60601-1-2 |
| Regulation: | 21CFR878.4810 | 21CFR878.4810 | 21CFR878.4810 |
| Comparison
Analysis: | The maximum power output of proposed device is between that of the two predicates devices,
and all of them comply with IEC 60825-1 and IEC 60601-2-22. So the difference will not
affect the safety and effectiveness of the proposed device. | | |
| Labeling: | Comply with the related
standards and refer to
Labeling documentation of
510(k) submission | Comply with the related
standards and refer to
Labeling documentation of
510(k) submission | Comply with the related
standards and refer to
Labeling documentation of
510(k) submission |
| Based on comparison above, the DC7 Dental Laser Therapy System shares the similar design features and
functional features with the predicate devices. | | | |
」·
5
- From a design and clinical perspective, the predicate and candidate laser Summary: device, are the same technology and have the same intended use. Based upon the fact that the devices are exactly the same or extremely similar, the DC 7 should not raise any concerns regarding its overall safety and/or effectiveness.
Non clinical Performance Data: None
6
Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or other bird-like figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 7, 2013
DC International LLC Mr. David Boegler Vice President 624 Cypress Green Circle Wellington, Florida 33414
Re: K131839
Trade/Device Name: DC7 Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: September 27, 2013 Received: October 7, 2013
Dear Mr. Boegler:
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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
7
Page 2 - Mr. David Boegler
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark Nijelkerson -S
Mark N. Melkerson Acting Director Division of Surgical Devices . Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
Indications for Use
510(k) Number: K131839
Device Name: DC 7
Indications For Use:
The DC 7 laser and accessories are indicated for General Surgery, Dermatology & Plastic Surgery, and Podiatry: Excision, ablation, vaporization, and photocoagulation of skin lesions, hemostasis; incision, excision, vaporization, and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissue, and dermabrasion, such as:
Matrixectomy Excision of neuromas Excision of periungual and subungual warts Excision of plantar warts Excision of Keloids Excision of cutaneous lesions Photocoagulation of telangiectasia, venulectasia of the legs and face Superficial benign vascular lesions including Telangiectasias, hemangioma, Port wine stains, angiokeratoma, and benign epidermal pigment lesions as lentigines. Epidermal nevi, spider nevi
× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Neil R Ogden -2013.11.08 11:01:26 -05'00'
(Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number K131839
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