(17 days)
Not Found
No
The device description and performance studies focus on the laser's power output and control, with no mention of AI or ML capabilities.
Yes
The "Intended Use / Indications for Use" section explicitly lists "treatment of apthous ulcers" and "sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket)," which are therapeutic applications. Additionally, the device description refers to it as a "dental surgical and therapeutic diode laser."
No
The device is a surgical and therapeutic laser used for ablating, vaporizing, and coagulating soft tissues, not for diagnosing conditions.
No
The device description clearly outlines multiple hardware components including a housing, optical fiber, hand piece, foot switch, and auxiliary power supply, in addition to the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "intracral soft tissue general, only maxills-facial and cosmetic surgery." It is used for ablating, vaporizing, and coagulation of soft tissues. This is a therapeutic and surgical application, not a diagnostic one.
- Device Description: The description details a laser unit designed to deliver energy to tissue. There is no mention of analyzing samples (like blood, urine, or tissue) or providing diagnostic information based on such analysis.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
The device is a surgical laser intended for direct treatment of tissue within the mouth and face.
N/A
Intended Use / Indications for Use
The SOL Portable Diode Laser Unit (with wireless foot control) is intental intracral soft tissue general, only maxills-facial and cosmetic surgery. It is intended for ablating, vaportizing and coagulation of soft tissues using a fiber optic delivery system. Include excision and incision biopsies; hemostatic assissance; treatment of apthous ulcers; frenotomy; gingival incision and excision; gingivectory; gingivoplasty; incisiog and draining abscesses; operculectomy; oral papillectomy; removal of fibromas; soft tissue crown lengthening; sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket); tissue retraction for impression; vestibuloplasty.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The SOL Portable Diode Laser Unit (with wireless foot control) has the same intended use and indications for use as the Sapphire Portable Diode Laser (K103667). It is an alternate construction, incorporating the same principles of operation in a more ergonomic industrial design package. The SOL Portable Diode Laser, or SOL, is a battery operated counter top dental surgical and therapeutic diode laser. The SOL comprises five main assemblies; a housing, an optical fiber with hand piece, and optical fiber "tip", a foot switch and an auxiliary power supply. The housing contains the system PCBs with system display, battery, control panel with indicators, auxiliary power and footswitch jacks, safety key switch, system power On/Off switch, diode laser with 808 nm working beam and 405 nm aiming beam, heat dissipation assembly with over temperature thermistor and fiber storage wrap. The optical fiber with hand piece comprises a single glass core fiber contained inside an outer PVC jacket, connectors for diode and tip coupling and a hand piece for precise delivery of laser energy to the target tissue. The optical fiber tip is a single patient disposable glass core fiber for delivery of laser energy to the target that couples to the hand piece fiber. A wireless foot control can be used to activate the laser working beam. The auxiliary power supply connects to the housing and is used to charge the system battery and as a power source for the diode laser in the event of low battery capacity.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intraoral 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)
The SOL Portable Diode Laser Unit (with wireless foot control) has been tested side-by-side against two of the predicate devices. Measurements of the output of the subject devices' working beam range from 0.1 to 3.0W output in Continuous Wave and Pulse modes were shown to vary from the unit's settings by an average of only 1.4% in CW and 0.5% in P compared to the predicate's variance of 2.2% in CW and 2.7% in P. The intended performance of these devices, based on IEC 60601-2-22, is that laser output should vary from the device's setting by less than ± 20% of the setting. Both the subject and predicate devices have been shown to satisfy this standard, with the subject device demonstrating less variability (more control) than the cleared predicate devices.
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.
Not Found
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
JUL 25 2014 SECTION 5
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR §807.92.
- Submitter's name, address, telephone number, contact person, and date summary 1. prepared:
| Submitter: | Den-Mat Holdings, LLC.
1017 West Central Ave.
Lompoc, CA 93436, USA
Tel. (805) 346-3700 |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Robert Wang, RAC
Regulatory Affairs Manager
Tel.: (805) 346-3700 Ext. 3767
(805) 346-3767 Direct
Fax: (805) 347-7940
E-mail: rwang@denmat.com |
April 11, 2014 Date Summary Prepared:
- Name of device, including the trade name and classification name: 2.
Trade/Proprietary Name: SOL Portable Diode Laser Unit (with wireless foot control)
Common Name: Powered laser surgical instrument
| Device Classification Name: | Regulation Number | Class | Product Code |
|---|---|---|---|
| Laser surgical-instrument for | |||
| use in general and plastic | |||
| surgery and in dermatology. | 878.4810 | II | GEX |
- Identification of the predicate device or legally marketed device or devices to which 3. substantial equivalence is being claimed:
1
K141838 Page 2 of 4 SOL Portable Diode Laser Unit (with wireless foot control) Traditional 510 (k) Premarket Notification
Submitter: DenMat Holdings, LLC
Den-Mat Holdings, LLC Company: Sapphire ST Portable Diode Laser Device: 510(k): K103667 Date Cleared: December 29, 2010 Company: Discus Dental, LLC Device: ST3 K102639 510(k): December 01, 2010 Date Cleared:
A description of the device that is the subject of the 510(k), including an explanation of 4. how the device functions, basic scientific concepts, significant physical and performance characteristics (design, material, physical properties):
The SOL Portable Diode Laser Unit (with wireless foot control) has the same intended use and indications for use as the Sapphire Portable Diode Laser (K103667). It is an alternate construction, incorporating the same principles of operation in a more ergonomic industrial design package. The SOL Portable Diode Laser, or SOL, is a battery operated counter top dental surgical and therapeutic diode laser. The SOL comprises five main assemblies; a housing, an optical fiber with hand piece, and optical fiber "tip", a foot switch and an auxiliary power supply. The housing contains the system PCBs with system display, battery, control panel with indicators, auxiliary power and footswitch jacks, safety key switch, system power On/Off switch, diode laser with 808 nm working beam and 405 nm aiming beam, heat dissipation assembly with over temperature thermistor and fiber storage wrap. The optical fiber with hand piece comprises a single glass core fiber contained inside an outer PVC jacket, connectors for diode and tip coupling and a hand piece for precise delivery of laser energy to the target tissue. The optical fiber tip is a single patient disposable glass core fiber for delivery of laser energy to the target that couples to the hand piece fiber. A wireless foot control can be used to activate the laser working beam. The auxiliary power supply connects to the housing and is used to charge the system battery and as a power source for the diode laser in the event of low battery capacity.
ડ. Statement of intended use:
The SOL Portable Diode Laser Unit (with wireless foot control) is a medical electrical device intended for use in dental intraoral soft tissue general, oral maxilla-facial and cosmetic surgery. It is intended for ablating, incising, vaporizing and coagulation of soft tissues using a fiber optic delivery system.
2
Statement of how the technological characteristics of the device compare to those of 6. the predicate or legally marketed device:
The proposed SOL Portable Diode Laser Unit (with wireless foot control) has the following technological similarities to the predicate devices:
- the equivalent working beam wavelength, ●
- the equivalent pulse control digital emission control, .
- the same laser source solid state diode, .
- . the equivalent user interface, and
- the equivalent wireless foot control .
Statement of how the functional characteristics of the device compare to those of 7. the predicate or legally marketed device:
The proposed SOL Portable Diode Laser Unit (with wireless foot control) has the following functional similarities to the predicate devices:
- . the equivalent indications for use,
- the same operating principle, .
- . the same basic construction,
- the same shelf life, and .
- the same packaging materials and processes. .
Comparative Performance Data: 8.
The SOL Portable Diode Laser Unit (with wireless foot control) has been tested side-by-side against two of the predicate devices. Measurements of the output of the subject devices' working beam range from 0.1 to 3.0W output in Continuous Wave and Pulse modes were shown to vary from the unit's settings by an average of only 1.4% in CW and 0.5% in P compared to the predicate's variance of 2.2% in CW and 2.7% in P. The intended performance of these devices, based on IEC 60601-2-22, is that laser output should vary from the device's setting by less than ± 20% of the setting. Both the subject and predicate devices have been shown to satisfy this standard, with the subject device demonstrating less variability (more control) than the cleared predicate devices.
Page 3 of 4
3
| 9. | Technological Characteristics |
|---|---|
| ---- | ------------------------------- |
| Device Name | SOL Portable Diode
Laser Unit (with
wireless foot control)
(Subject Device) | Sapphire ST Portable
Diode Laser
(Predicate Device) | SL3.
(Predicate Device) |
|-----------------------|-----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|------------------------------|
| Manufacturer | DenMat Holding, LLC | DenMat Holding, LLC | Discus Dental, LLC |
| 510(k)
Number | KXXXXXXX | K103667 | K102639 |
| Wavelength | $808 \pm 5$ nm | $808 \pm 5$ nm | $808 \pm 10$ nm |
| Power | 3 Watts | 3 Watts | 3 Watts |
| Aiming Bean | $405 \pm 10$ nm,
max. 5 mW | $640 \pm 10$ nm,
max. 2 mW | 650 nm,
max. 5 mW |
| Cooling
System | Convection cooled | Convection cooled | Convection cooled |
| Pulse Control | Digital emission control | Digital emission control | Unknown |
| Laser Source | Solid-state diode | Solid-state diode | Solid-state diode |
| Power
Requirements | 24W 5VDC supplied from
110-120 VCA @ 60 Hz or
220–240 VAC @ 50 Hz
(switchable) | 24W 5VDC supplied from
110-120 VCA @ 60 Hz or
220–240 VAC @ 50 Hz
(switchable) | 100 - 240 VAC,
50 - 60 Hz |
| User
Interface | Membrane touch pad,
LCD Display, LED
Indicators | Membrane touch pad,
LCD Display, LED
Indicators | LCD Touch screen |
| Fiberoptic
Tip | Disposable,
400 um
Unit dose | Disposable,
400 um
Unit dose | Unknown |
10. Conclusions:
The SOL Portable Diode Laser Unit (with wireless foot control) has the equivalent indications for use and technological characteristics as that of the predicate devices. The minor technological and material differences exist between the SOL Portable Diode Laser Unit (with wireless foot control) and its predicate devices raise no new questions of safety or effectiveness. Performance data demonstrate that the SOL Portable Diode Laser Unit (with wireless foot control) is as safe, as effective, and performs as well as or better than the DenMat, Sapphire ST Portable Diode Laser (K103667) and Discus Dental, SL3 (K102639). Therefore, it can be concluded that the SOL Portable Diode Laser Unit (with wireless foot control) is substantially equivalent to the predicate devices.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES - USA
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 25, 2014
Den-Mat Holdings, LLC Mr. Robert Wang, RAC Regulatory Affairs Manager 1017 West Central Avenue Lompac. California 93436
Rc: K141838
Trade/Device Name: SOL Portable Diode Laser Unit (with wireless foot control) 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: July 8, 2014 Received: July 10, 2014
Dear Mr. Wang:
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
5
Page 2 - Mr. Robert Wang, RAC
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 Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.goy/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
David= David= S
- · Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
SOL Portable Diode Laser Unit (with wireless foot control)
Indications for Use (Describe)
The SOL Portable Diode Laser Unit (with wireless foot control) is intental intracral soft tissue general, only maxills-facial and cosmetic surgery. It is intended for ablating, vaportizing and coagulation of soft tissues using a fiber optic delivery system. Include excision and incision biopsies; hemostatic assissance; treatment of apthous ulcers; frenotomy; gingival incision and excision; gingivectory; gingivoplasty; incisiog and draining abscesses; operculectomy; oral papillectomy; removal of fibromas; soft tissue crown lengthening; sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket); tissue retraction for impression; vestibuloplasty.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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nourence of Center for Devices and Radiological Health (CDRH) (Signature)
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