(78 days)
Not Found
No
The summary describes a diode laser for soft tissue surgery and does not mention any AI or ML capabilities.
Yes
The device is used for various soft tissue surgical procedures, including biopsies, treatment of ulcers, frenectomy, gingivectomy, and tissue removal, which are all therapeutic interventions aimed at treating medical conditions.
No
The provided text describes the device's intended use for surgical and cosmetic procedures, such as biopsies, excisions, and tissue alterations, not for diagnosing conditions.
No
The device description explicitly states it is a Class IV soft-tissue diode laser that uses a Gallium, Aluminum, Arsenic (GaAIAS) diode and delivers energy through optical fiber, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for oral soft tissue surgery and other procedures performed directly on the patient's body (in vivo). IVD devices are used to examine specimens (like blood, urine, or tissue samples) outside of the body (in vitro) to provide information about a person's health.
- Device Description: The device description details a laser used for surgical procedures, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, reagents, or any of the typical components or processes associated with in vitro diagnostics.
Therefore, the SL3™ is a surgical laser device, not an IVD.
N/A
Intended Use / Indications for Use
The SL3™ is intended to be used for oral soft tissue surgery, including: biopsies, hemostatic assistance; treatment of apthous ulcers; frenectomy; gingival incision and excision; gingivectomy; gingivoplasty; incising and draining of abscesses; operculectomy; removal of fibromas; soft-tissue crown lengthening; sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket) and tissue retraction for impressions.
The SL3 laser is to provide the ability to perform intraoral soft tissue dental, general, oral maxilla-facial and cosmetic surgery. The SL3 laser is intended for ablating, incising, vaporizing and coagulation of soft tissues using a contact fiber optic delivery system.
The device will be used in the following areas: general and cosmetic dentistry, otolaryngology, arthroscopy, gastroenterology, general surgery, dermatology & plastic surgery, genecology, urology, opthamology and pulmonary surgery. The following are the oralpharngeal indications for use for which the device will be marketed:
-Excision and Incision Biopsies
-Hemostatic assistance
-Treatment of Apthous Ulcers
-Frenectomy
-Frenotomy
-Gingival Incision and Excision
-Gingivectomy
-Gingivoplasty
-Incising and Draining of 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
-Light activation of bleaching materials for teeth whitening
-Laser-assisted bleaching/whitening of teeth
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The SL3™ is a Class IV soft-tissue diode laser that can be used for a wide variety of soft-tissue procedures. This device uses a Gallium, Aluminum, Arsenic (GaAIAS) diode for the active medium, producing laser energy at 810 nanometer wavelength. Laser technology has been steadily evolving, allowing doctors to provide less invasive treatment for many dental procedures, both preventative and restorative. The SL3™ is designed to be compact, portable, reliable and user friendly. It provides the practitioner with a versatile instrument for applications ranging from excisions to vaporization of tissues. The diode laser energy is delivered through optical fiber in the hand piece to the removable fiber tips. The system may be utilized for a wide variety of surgical and cosmetic procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral soft tissue, oralpharngeal
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)
Not Found
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
510(k) Summary
DEC 1 2010
-
- Contact Person:
Clark D. vonAhsen Regulatory Affairs Discus Dental, LLC 8550 Higuera Street · Culver City, CA 90232 310.845.8216 - phone 310.845.8647 - fax clarkv@discusdental.com
- Contact Person:
Date of Summary Preparation: 11/30/2010
Name of Medical Device: 2.
| Proprietary Name: | SL3 |
|---|---|
| Common/Usual Name: | Surgical Laser System |
| Classification Name: | Laser, Surgical (21 CFR 878.4810 Product Code GEX) |
3. Substantial Equivalence:
The SL3 is substantially equivalent to the following commercially marketed product
| Predicate Device | Company | 510(k) No. |
|---|---|---|
| SoftLase Pro | Zap Lasers, LLC | K091796 |
| Styla | Zap Lasers, LLC | K081214 |
4. Description of Device:
The SL3™ is a Class IV soft-tissue diode laser that can be used for a wide variety of soft-tissue procedures. This device uses a Gallium, Aluminum, Arsenic (GaAIAS) diode for the active medium, producing laser energy at 810 nanometer wavelength. Laser technology has been steadily evolving, allowing doctors to provide less invasive treatment for many dental procedures, both preventative and restorative. The SL3™ is designed to be compact, portable, reliable and user friendly. It provides the practitioner with a versatile instrument for applications ranging from excisions to vaporization of tissues. The diode laser energy is delivered through optical fiber in the hand piece to the removable fiber tips. The system may be utilized for a wide variety of surgical and cosmetic procedures.
1
5. Intended Use
The SL3™ is intended to be used for oral soft tissue surgery, including: biopsies, hemostatic assistance; treatment of apthous ulcers; frenectomy; gingival incision and excision; gingivectomy; gingivoplasty; incising and draining of abscesses; operculectomy; removal of fibromas; soft-tissue crown lengthening; sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket) and tissue retraction for impressions.
6. Summary of Technological Characteristics
| Discus Dental, LLC | Zap Laser, LLC | Zap Laser, LLC | |
|---|---|---|---|
| Name | --- | --- | --- |
| SL3 | Softlase Pro | Styla | |
| 510(k) number | K102639 | K091796 | K081214 |
| Type of laser | Diode laser | Diode laser | Diode laser |
| Wavelength | $808 \pm 10$ nm | $808 \pm 5$ nm | $808 \pm 5$ nm |
| Max output | |||
| power | 3.0 Watt | 2.0 Watt | 2.0 Watt |
| Power | |||
| requirements | 100-240 VAC, @ 50-60 | ||
| Hz, 1A | 100-240 VAC, @ 50-60 | ||
| Hz, 1A | 90-240 VAC @ 50-60 Hz, | ||
| 0.8A | |||
| Battery | Corded or battery | ||
| operation | Corded - no battery | Battery operated | |
| Operation mode | Continuous wave and | ||
| pulsed | Continuous wave and | ||
| pulsed | Continuous wave and | ||
| pulsed | |||
| Delivery system | 400 um core quartz fiber | 400 um core quartz fiber | 400 um core quartz fiber |
| Fiber | FC connector to | ||
| handpiece - Disposable tip | |||
| magnetically attached to | |||
| handpiece | SMA 905 connector to | ||
| handpiece - perpetual | |||
| fiber | Disposable tip | ||
| magnetically attached to | |||
| handpiece | |||
| Fiber aiming | |||
| beam | 5 mw diode laser, 650 nm | 5 mw diode laser, 650 nm | 5 mw diode laser, 650 nm |
| Activation means | Wireless foot switch - | ||
| takes 2 AA batteries | Corded foot switch | Wireless foot switch - | |
| takes 2 AA batteries | |||
| Interface | Color LCD touch-screen | ||
| GUI on desk unit displays | |||
| 8 pre-set procedures or | |||
| manual control to set | |||
| power and laser mode | |||
| (continuous or pulse) | Color LCD touch-screen | ||
| GUI on desk unit displays | |||
| 8 pre-set procedures or | |||
| manual control to set | |||
| power and laser mode | |||
| (continuous or pulse) | OLED on handpiece | ||
| displays 8 pre-set | |||
| procedures or manual | |||
| control to set power and | |||
| laser mode (continuous or | |||
| pulse) | |||
| Diode Assembly | 3 watt single emitter | ||
| diode lasing at 808 nm | 2.5 watt single emitter | ||
| diode lasing at 808 nm | 2.0 watt single emitter | ||
| diode lasing at 808 nm | |||
| Cooling system | Heat sink | Fan | Heat sink |
| Laser diode | |||
| power supply | External | Internal | External |
| Intended Use / | -Excision and Incision | -Excision and Incision | -Excision and Incision |
| Indications for | Biopsies | Biopsies | Biopsies |
| Use | -Hemostatic assistance | -Hemostatic assistance | -Hemostatic assistance |
| -Treatment of Apthous | |||
| Ulcers | -Treatment of Apthous | ||
| Ulcers | -Treatment of Apthous | ||
| Ulcers | |||
| -Frenectomy | -Frenectomy | -Frenectomy | |
| -Frenotomy | -Frenotomy | -Frenotomy | |
| -Gingival Incision and | |||
| Excision | -Gingival Incision and | ||
| Excision | -Gingival Incision and | ||
| Excision | |||
| -Gingivectomy | -Gingivectomy | -Gingivectomy | |
| -Gingivoplasty | -Gingivoplasty | -Gingivoplasty | |
| -Incising and Draining of | |||
| Abscesses | -Incising and Draining of | ||
| Abscesses | -Incising and Draining of | ||
| Abscesses | |||
| -Operculectomy | -Operculectomy | -Operculectomy |
2
.
3
| -Oral Papillectomy | -Oral Papillectomy | -Oral Papillectomy |
|---|---|---|
| -Removal of Fibromas | -Removal of Fibromas | -Removal of Fibromas |
| -Exposure of unerupted | -Exposure of unerupted | -Exposure of unerupted |
| teeth | teeth | teeth |
| -Soft Tissue Crown | -Soft Tissue Crown | -Soft Tissue Crown |
| Lengthening | Lengthening | Lengthening |
| -Sulcular Debridement | -Sulcular Debridement | -Sulcular Debridement |
| (removal of diseased or | (removal of diseased or | (removal of diseased or |
| inflamed soft tissue in the | inflamed soft tissue in the | inflamed soft tissue in the |
| periodontal pocket) | periodontal pocket) | periodontal pocket) |
| -Tissue retraction for | -Tissue retraction for | -Tissue retraction for |
| Impression | Impression | Impression |
| -Vestibuloplasty | -Vestibuloplasty | -Vestibuloplasty |
| -Light activation of | -Light activation of | -Light activation of |
| bleaching materials for | bleaching materials for | bleaching materials for |
| teeth whitening | teeth whitening | teeth whitening |
| -Laser-assisted bleaching / | -Laser-assisted bleaching / | -Laser-assisted bleaching / |
| whitening of teeth | whitening of teeth | whitening of teeth |
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
1 2010 DEC
Discus Dental, LLC % Mr. Clark D. vonAhsen Regulatory Affairs 8550 Higuera Street Culver City, California 90232
Re: K102639
Trade/Device Name: SL3 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: November 18, 2010 Received: November 24, 2010
Dear Mr. vonAhsen:
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.
5
Page 2 – Mr. Clark D. vonAhsen
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Molkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use Statement
510(k) Number (if known):
(Part 21 CFR 801 Subpart D)
Device Name: ਨ। ਤ
Indications for Use:
The SL3 laser is to provide the ability to perform intraoral soft tissue dental, general, oral maxilla-facial and cosmetic surgery. The SL3 laser is intended for ablating, incising, vaporizing and coagulation of soft tissues using a contact fiber optic delivery system.
The device will be used in the following areas: general and cosmetic dentistry, otolaryngology, arthroscopy, gastroenterology, general surgery, dermatology & plastic surgery, genecology, urology, opthamology and pulmonary surgery. The following are the oralpharngeal indications for use for which the device will be marketed:
-Excision and Incision Biopsies -Hemostatic assistance -Treatment of Apthous Ulcers -Frenectomy -Frenotomy -Gingival Incision and Excision -Gingivectomy -Gingivoplasty -Incising and Draining of 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 -Light activation of bleaching materials for teeth whitening -Laser-assisted bleaching/whitening of teeth Over-The-Counter Use Prescription Use OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
510(k) Number K102639