(29 days)
Not Found
No
The description focuses on the laser technology and its physical effects on tissue, with no mention of AI or ML for analysis, decision-making, or control.
Yes
The device is used for various dental soft tissue applications, including incision, excision, vaporization, ablation, and coagulation of oral soft tissues, and is intended to treat specific oral conditions and perform therapeutic procedures.
No
The device description indicates that the system is used to "incise, excise, vaporize, coagulate and ablate intraoral soft tissues," and the indications for use list various surgical and therapeutic procedures. There is no mention of the device being used to identify, analyze, or characterize disease states or conditions.
No
The device description explicitly states it is a "dental diode laser system" that uses a "solid-state laser diode" and transmits energy via a "flexible fiberoptic cable to the handpiece." These are hardware components, not solely software.
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 description clearly states that the ezlase™ 10W dental diode laser system is used to perform procedures directly on oral soft tissues. It incises, excises, vaporizes, coagulates, and ablates tissue.
- Lack of Sample Analysis: There is no mention of the device analyzing samples taken from the body. Its function is to directly interact with the patient's tissue.
Therefore, this device falls under the category of a surgical or therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Dental Soft Tissue Indications for:
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 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
- Vestibuloplasty
Laser Periodontal procedures, including:
- Laser soft tissue curettage
- 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 index, gingival bleeding index, probe depth, attachment loss and tooth mobility.)
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The ezlase™ 10W dental diode laser system may be used to perform various dental soft tissue applications. The system uses advanced laser technology to incise, excise, vaporize, coagulate and ablate intraoral soft tissues. An Indium Gallium Arsenide Phosphorus solid-state laser diode emits infrared laser energy to the various oral soft tissues targeted during a procedure. This energy is transmitted via a flexible fiberoptic cable to the handpiece that emits the energy to the targeted tissue site. A visible light is emitted at the same time to visually pinpoint the treatment location. The power output and pulse width may be adjusted to specific user requirements.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral soft tissues, intraoral soft 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
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
NOV 1 3 2008
Biolase Technology, Inc. Special 510(k) Summary Statement ezluse™ 10W CONFIDENTIAL
510(k) SPECIAL Summary (As required by 21CFR807.92, 21CFR807.81(a)(3), FDA Mcmorandum #K97-1)
| Date Prepared: | October 13, 2008 |
|---|---|
| Company: | Biolase Technology, Inc. |
| 4 Cromwell | |
| Irvine, CA 92618 | |
| Tel: (949) 361-1200 | |
| Fax: (949) 273-6680 | |
| Contact: | Ms. Ioana M. Rizoiu |
| VP, Clinical R&D | |
| Tel: (949) 226-8144 | |
| email: irizoiu@biolase.com | |
| Trade Name: | ezlase™ 10W |
| Common Name: | Dental Diode Laser |
| Classification Name: | Surgical laser instrument |
| Classification Code: | 79 GEX, a Class II device |
| Predicate Devices: | ezlase™ |
| Biolase Technology, Inc | |
| K061898 (January 26, 2007) |
Twilight™
Biolase Technology, Inc
K991994 (September 10, 1999) |
DEVICE DESCRIPTION:
The ezlase™ 10W dental diode laser system may be used to perform various dental soft tissue applications. The system uses advanced laser technology to incise, excise, vaporize, coagulate and ablate intraoral soft tissues. An Indium Gallium Arsenide Phosphorus solid-state laser diode emits infrared laser energy to the various oral soft tissues targeted during a procedure. This energy is transmitted via a flexible fiberoptic cable to the handpiece that emits the energy to the targeted tissue site. A visible light is emitted at the same time to visually pinpoint the treatment location. The power output and pulse width may be adjusted to specific user requirements.
1
INDICATIONS FOR USE:
Dental Soft Tissue Indications for:
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
- A Fibroma removal
- A Frenectomy
- V Frenotomy
- A Gingival troughing for crown impressions
- ア Gingivectomy
- ア Gingivoplasty
- ﺗﯜ Gingival incision and excision
- ﺮ Hemostasis and coagulation
- ア Implant recovery
- ア Incision and drainage of abscess
- ア Leukoplakia
- ﺮ Operculectomy
- ア Oral papillectomies
-
Pulpotomy
- ア Pulpotomy as an adjunct to root canal therapy
- ﻟﻠﺘﺮ Reduction of gingival hypertrophy
- Soft tissue crown lengthening A
- A Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa
- A Vestibuloplasty
Laser Periodontal procedures, including:
- A Laser soft tissue curettage
- A Laser removal of discased, inflamed and necrosed soft tissue within the periodontal pocket
- A 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 mobility.)
CONTRAINDICATIONS:
All clinical procedures performed with the ezlase™ 10W must be subjected to the same clinical judgment and care as with traditional techniques. Patient risk must always be considered and fully understood before clinical treatment. The clinician must completely understand the patient's medical history prior to treatment. Exercise caution for general medical conditions, which might contraindicate a local procedure. Such conditions may include allergy to local or topical anesthetics, heart disease, lung disease, bleeding disorders, sleep apnea, and immune system deficiency, or any medical conditions or medications that may contraindicate use of certain
2
light/laser type sources associated with this device. Medical clearance from the patient's physician is advisable when doubt exists regarding treatment.
CONCLUSION:
There are no new indications requested for this device in this Special 510(k). Substantial equivalency for the ezlaxe™ 10W has been determined through comparison to previously claared devices.
3
Image /page/3/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biolase Technology, Inc. % Ms. Ioana Rizoiu VP, Clinical Research & Development 4 Cromwell Irvine, California 92618
NOV 1 3 2008
Re: K083069 Trade/Device Name: ezlase™ 10W Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: October 13, 2008 Received: October 15, 2008
Dear Ms. Rizoiu:
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 cnactment 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); labcling (21 CFR Part 801); 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.
4
Page 2 - Ms. Ioana Rizoiu
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket survcillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Survcillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilitics under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mark N. Wilkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
510(k) Number: K 08306
Device (Trade) Name: ezlase™ 10W
Indications for Use:
Dental Soft Tissue Indications for:
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 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
- ▷ Vestibuloplasty
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K083069
6
Laser Periodontal procedures, including:
-
Laser soft tissue curettage
-
Lascr removal of discased, 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 mobility.)
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-the-Counter Use_ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) (Division Sign of General, Restorative, Division of Neurological Devices
510(k) Number K083069