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, Tissue retraction for impression. Laser Periodontal procedures, including: Laser soft tissue curettage, Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket, Sulcular debridement (removal of diseased, infected, 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.)

Device Description

The iLase™ dental soft tissue laser is a surgical device designed for a wide variety of dental soft tissue procedures. It is capable of storing up to twelve soft tissue procedure settings. The iLase™ uses a solid state laser diode as a source of invisible infrared radiation. The energy is delivered to the treatment site via the ezTip® a single-use fiber optic tip assembly. Several types of ezTips® are available for use with the iLase™ to perform different procedures. The iLase™ is a Class II medical laser device and is sold only to licensed practitioners. The iLase™ system consists of two elements: I. The handpiece contains the laser diode, the replaceable fiber optic ezTip®, removable shroud, a microprocessor, control program, memory, integrated finger switch, organic LED (OLED) display, and rechargeable battery. The handpiece delivers laser energy, under user control, to the treatment site. II. The battery charger is used for charging and storing the handpiece. Discharged batteries are placed in receptacles in the charging station where they are automatically recharged. The charging station is furnished with a low voltage power supply.

AI/ML Overview

The provided text does not contain information about acceptance criteria and a study proving the device meets those criteria. The document is a 510(k) summary statement for the iLase™ dental diode laser, focusing on demonstrating substantial equivalence to predicate devices rather than presenting performance study results against specific acceptance criteria.

The document includes:

Device description
Indications for use
Contraindications
A conclusion of substantial equivalence
An official FDA letter confirming clearance

It explicitly states: "Substantial equivalency for the iLase™ has been determined through comparison to previously cleared dental diode lasers." This indicates that the regulatory clearance was based on similarity to existing devices, not on a new clinical performance study with defined acceptance criteria.

Therefore, I cannot provide the requested table or answer the questions related to sample size, ground truth, expert opinions, or MRMC studies, as this information is not present in the provided text.

Summary

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K093852

CONFIDENTIAL

MAR 1 2 2010

Biolase Technology, Inc. 510(k) Summary Statement iLase

510(k) Summary of Safety and Effectiveness (As required by 21CFR807.92, 21CFR807.81(a)(3), FDA Memorandum #K97-1)

Date Prepared:	March 3, 2010
Company:	Biolase Technology, Inc.
	4 Cromwell
	Irvine, CA 92618
	Tel: (949) 361-1200
Contact:	Ms. Ioana M. Rizoiu
	VP, Clinical R&D
	Tel: (949) 226-8144
	Fax: (949) 273-6680
	email: irizoiu@biolase.com
Trade Name:	iLase TM
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 (1/26/07), K083069 (11/13/08)
	Styla Microlaser
	Zap Lasers, LLC

DEVICE DESCRIPTION:

The iLase™ dental soft tissue laser is a surgical device designed for a wide variety of dental soft tissue procedures. It is capable of storing up to twelve soft tissue procedure settings.

K081214 (5/14/2008)

The iLase™ uses a solid state laser diode as a source of invisible infrared radiation. The energy is delivered to the treatment site via the ezTip® a single-use fiber optic tip assembly. Several types of ezTips® are available for use with the iLase™ to perform different procedures. The iLase™ is a Class II medical laser device and is sold only to licensed practitioners.

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K093 852

Biolase Technology, Inc. 10(k) Summary Statement iLase

The iLase™ system consists of two elements:

L The handpiece contains the laser diode, the replaceable fiber optic ezTip®, removable shroud, a microprocessor, control program, memory, integrated finger switch, organic LED (OLED) display, and rechargeable battery. The handpiece delivers laser energy, under user control, to the treatment site.
II. The battery charger is used for charging and storing the handpiece. Discharged batteries are placed in receptacles in the charging station where they are automatically recharged. The charging station is furnished with a low voltage power supply.

INDICATIONS FOR USE:

Dental Soft Tissue Indications:

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
. Tissue retraction for impression

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).

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K093852

Biolase Technology, Inc. 510(k) Summary Statement iLase

CONTRAINDICATIONS:

All clinical procedures performed with the iLase™ 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 that might contraindicate a local procedure. Such conditions may include allergy to local or topical anesthetics, heart disease, bleeding disorders, and immune system deficiency, or any medical conditions or medications that may contraindicate use of certain light/laser type sources associated with this device. Medical clearance from patient's physician is advisable when doubt exists regarding treatment.

CONCLUSION:

iLase™ is substantially equivalent to devices previously cleared for marketing. iLase™ performs the same indications for use through the same mechanism as other devices cleared by the FDA. Substantial equivalency for the iLase™ has been determined through comparison to previously cleared dental diode lasers.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human figures or birds in flight. The symbol is black, and the text is also in black.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

MAR 1 2 2010

Biolase Technology, Inc. % Ms. Ioana M. Rizoiu Vice President, Clinical R & D 4 Cromwell Irvine, California 92618

Re: K093852

Trade/Device Name: iLase™ 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: March 04, 2010 Received: March 09, 2010

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 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

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Page 2 - Ms. Ioana M. Rizoiu

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/SafetyReportaProblem/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,

ely yours,

for No. V

N. Mello

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number: K 093852

Device (Trade) Name: iLase™

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
Tissue retraction for impression

Laser Periodontal procedures, including:

Laser soft tissue curettage
Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket

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Sulcular debridement (removal of diseased, infected, 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 of Surgical, Orthopedic,
and Restorative Devices

510(k) Number. /2093852

Regulation Number and Section

§ 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.