(72 days)
Not Found
No
The document describes a diode laser system for dental surgery and does not mention any AI or ML capabilities. The focus is on the laser's function for tissue manipulation.
Yes
Explanation: The device is intended for various therapeutic procedures involving soft tissue, such as frenectomy, gingivectomy, hemostasis, and removal of hyperplastic tissues, all of which aim to treat medical conditions or improve physical function.
No
The device description and intended use indicate that it is a surgical laser system used for procedures like incision, excision, hemostasis, and tissue removal (ablation), which are all therapeutic or interventional actions, not diagnostic ones. There is no mention of it analyzing or identifying medical conditions.
No
The device description explicitly states it is a "portable instrument" and uses a "contact fiber optic delivery system," indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The GENTLEray 980 Diode Dental Laser System is a surgical instrument used for treating soft tissue through ablation, incision, excision, and coagulation. It directly interacts with the patient's tissue.
- Lack of Diagnostic Activity: The description does not mention any analysis of samples or diagnostic testing. Its purpose is therapeutic and surgical, not diagnostic.
Therefore, the GENTLEray 980 Diode Dental Laser System falls under the category of a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue.
The GENTLEray 980 Diode Dental Laser System is intended for use in the following procedures: Frenectomy, Frenotomy, Biopsy, Operculectomy, Implant Recovery, Gingivectomy, Gingivoplasty, Gingival Troughing, Crown Lengthening, Hemostasis of Donor Site, Removal of Granulation Tissue, Laser-assisted Flan Singgry, Debridement of Deseased Epithelial Lining, Incisions and Draining of Abscesses, Tissue Retraction for Impressions, Papillectomy, Vestibuloplasty, Excision of Lesions, Leukoplakia, Exposure of Unerupted/Partially Erupted Teeth, Removal of Hyperplastic Tissues, Treatment of Aphthous Ulcers, Sulcular Debridement, Pulpotomy, Pulpotomy as an Adjunct to Root Canal Therapy, and Light Activation of Bleaching Materials.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The GENTLEray 980 Diode Dental Laser System is a portable instrument intended for ablating, incising, excising, and coagulating intraoral soft tissue (including the marginal and interdental gingiva) using a contact fiber optic delivery system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Intra- and extra-oral soft tissue, marginal and interdental gingiva, pulpal tissues.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing to validate the safety and effectiveness of the GENTLEray 980 Diode Dental Laser System includes electrical safety, electromagnetic compatibility, and validation testing of both hardware and software functions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
K983058, K991891, K023547, K063152
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
KO 72262
Image /page/0/Picture/1 description: The image contains two logos, one on the left and one on the right. The logo on the left is a stylized design, while the logo on the right contains the words "GENDEX" on the top line and "DEXIS" on the bottom line. The text in the logos is in a simple, sans-serif font.
| Applicant: | KaVo Dental Corporation | OCT 26 2007 |
|---|---|---|
| Address: | 340 East Main Street | |
| Lake Zurich, IL 60047 | ||
| USA | ||
| Phone Number: | ||
| Fax Number: | 847-550-6800 | |
| 847-550-6825 | ||
| Contact Person: | Mari Lambert | |
| Summary Prepared: | October 4, 2007 | |
| Name of Device: | KaVO GENTLEray 980 | |
| Trade Name: | GENTLEray 980 | |
| Common Name: | GENTLEray | |
| Classification Name: | Laser surgical instrument for use in general and plastic surgery | |
| and in dermatology | ||
| CFR Number: | 21 CFR §878.4810 | |
| Product Code: | GEX | |
| Product Description: | The GENTLEray 980 Diode Dental Laser System is a portable | |
| instrument intended for ablating, incising, excising, and | ||
| coagulating intraoral soft tissue (including the marginal and | ||
| interdental gingiva) using a contact fiber optic delivery system. | ||
| Intended Use: | Intra- and extra-oral surgery including incision, excision, | |
| hemostasis, coagulation and vaporization of soft tissue. | ||
| The GENTLEray 980 Diode Dental Laser System is intended for | ||
| use in the following procedures: 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 Deseased Epithelial | ||
| Lining, Incisions and Draining of Abscesses, Tissue Retraction | ||
| for Impressions, Papillectomy, Vestibuloplasty, Excision of | ||
| Lesions, Leukoplakia, Exposure of Unerupted/Partially Erupted | ||
| Teeth, Removal of Hyperplastic Tissues, Treatment of Aphthous | ||
| Ulcers, Sulcular Debridement, Pulpotomy, Pulpotomy as an | ||
| Adjunct to Root Canal Therapy, and Light Activation of | ||
| Performance | ||
| Standards: | The GENTLEray 980 Diode Dental Laser System complies with | |
| the appropriate sections of 21 CFR §1010 and 21 CFR §1040. | ||
| Substantial | ||
| Equivalence: | The GENTLEray 980 Diode Dental Laser System has the same | |
| intended use and the same or substantially equivalent technical | ||
| specifications and mechanism of action as compared with the | ||
| named predicated devices. The KaVo GENTLEray 980 Diode | ||
| Laser is substantially equivalent to the Ceramoptec Ceralas D15 | ||
| (K983058, K991891) sold latterly under the BioLitec brand | ||
| name SmilePro™ 980, the ADT Diolase 980 D Laser System | ||
| (K023547) and the Elexxion Claros (K063152). Performance | ||
| testing to validate the safety and effectiveness of the | ||
| GENTLEray 980 Diode Dental Laser System includes electrical | ||
| safety, electromagnetic compatibility, and validation testing of | ||
| both hardware and software functions. The comparison of | ||
| specifications are as follows: |
1
KO72262
| Specifications | Proposed Device | Predicate Device | Predicate Device | Predicate Device |
|---|---|---|---|---|
| Wavelength | KaVo GENTLEray 980 | Biolitec Smilepro 980 | ADT Diolase 980 D | Elexxion Claros |
| 980 nm | 980 nm | 980 nm | 810 nm | |
| Output Power | 12W | 15W | 15 W | 30 W |
| Power Range | .4 - 12W | 1-15W | .2 - 15 W | 0.01W - 30 W |
| Increments | .2 - 1W | 1W | .2 - 1W | 0.01W - 1 W |
| Operating Modes | Pulsed or Continuous | Pulsed or Continuous | Pulsed or Continuous | Pulsed or Continuous |
| Pulse Duration ON | 25μs to 99.9 Sec. | 0.01 to 99.9 Sec. | 0.01 to 99.9 Sec | 25μs to 99.9 Sec. |
| Pulse Duration OFF | 25μs to 99.9 Sec. | 0.01 to 99.9 Sec. | 0.01 to 99.9 Sec | 25μs to 99.9 Sec. |
| Frequency | 20.000 Hz | 100 Hz | 100 Hz | 20.000 Hz |
| Aiming beam | 635 nm, |