TWILIGHT

K991994 · Biolase Technology, Inc. · GEX · Sep 10, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K991994
• Device Name: TWILIGHT
• Applicant: Biolase Technology, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Sep 10, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Incision, excision, vaporization, ablation and coagulation of oral soft tissues including: Excisional and incisional biopsies Exposure of unerupted teeth Fibroma removal Frenectomy and frenotomy Gingival troughing for crown impressions Gingivectomy Gingivoplasty Gingival incision and excision Hemostasis Implant recovery Incision and drainage of abscess Laser Assisted Uvulopaletoplasty (LAUP) This laser is effective for cutting, ablating, coagulating and removing oropharangeal soft tissue that has been diagnosed as anatomically abnormal or naturally occurring hypertrophic which has been identified and confirmed as being associated with chroninc palatal snoring. Leukoplakia Operculectomy Oral papillectomies Pulpotomy Pulpotomy as an adjunct to root canal therapy Reduction of gingival hypertrophy Reduction of bacterial level (decontamination) and inflammation Soft tissue crown lengthening Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility) Treatment of aphthous ulcers Vestibuloplasty

Device Story

Twilight™ is a dental diode laser system using a Gallium Aluminum Arsenide (GaAIAs) solid-state laser diode to generate optical energy. The device is operated by a clinician in a dental office setting. Energy is delivered via a flexible fiberoptic handpiece; a visible light beam at the distal end assists in targeting treatment areas. The clinician adjusts optical power and pulse settings based on the specific surgical application. The laser energy incises, excises, ablates, and coagulates soft tissue. By providing precise tissue removal and hemostasis, the device facilitates various oral surgeries, including biopsies, gingival procedures, and periodontal debridement, potentially reducing patient discomfort and improving healing compared to traditional surgical techniques.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing, performance specifications, and comparison to legally marketed predicate devices.

Technological Characteristics

Gallium Aluminum Arsenide (GaAIAs) solid-state laser diode; flexible fiberoptic handpiece delivery system; adjustable optical power and pulse settings; visible aiming beam; Class II surgical laser instrument.

Indications for Use

Indicated for incision, excision, vaporization, ablation, and coagulation of oral soft tissues in patients requiring dental surgical procedures, including biopsies, gingivectomy, frenectomy, and treatment of periodontal disease or snoring-related oropharyngeal hypertrophy. Contraindicated in patients with conditions where local procedures are inadvisable, such as allergies to anesthetics, heart/lung disease, bleeding disorders, sleep apnea, or immune deficiencies.

Regulatory Classification

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.

Predicate Devices

• PulseMaster™ (K972325)
• LD-15™ (K974057)
• Aurora™ (K954316)
• Aurora™ (K981379)
• PulseMaster™ (K961269)
• Aurora™ (K974586)

Submission Summary (Full Text)

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SEP 1 0 1999

# K991994

510(k) Summary of Safety and Effectiveness Information

| Regulatory<br>Authority: | Safe Medical Devices Act of 1990,<br>21 CFR 807.92 |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Company: | BioLase Technology, Inc.<br>981 Calle Amanecer<br>San Clemente, California 92673 |
| Contact: | Ms. Ioana M. Rizoiu<br>BioLase Technology, Inc.<br>981 Calle Amanecer<br>San Clemente, California 92673<br>[phone] [phone] Fax |
| Trade Name: | Twilight™ |
| Common Name: | Dental diode laser |
| Classification Name: | Surgical laser instrument |
| Classification Code: | 79 GEX |
| Equivalent Devices: | |
| American Dental Technologies | PulseMaster™ |
| Dentek-LaserSystems | LD-15™ |
| Premier Laser Systems | Aurora™ |

## Device Description:

The Twilight™ dental diode laser system may be used to perform several dental applications. Twilight™ uses advanced laser technology to incise, excise and ablate intraoral soft tissues safely and effectively. A Gallium Aluminum Arsenide (GaAIAs) solid state laser diode provides optical energy to oral soft tissues.

A flexible fiberoptic handpiece delivers the Twilight™ laser energy. A visible light emitted from the handpiece distal end pinpoints the area of treatment. The optical power output and pulse may be adjusted to specific user requirements.

#### Indications for Use:

Incision, excision, vaporization, ablation and coagulation of oral soft tissues including:

Excisional and incisional biopsies Exposure of unerupted teeth Fibroma removal Frenectomy and frenotomy

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Gingival troughing for crown impressions Gingivectomy Gingivoplasty Gingival incision and excision Hemostasis Implant recovery Incision and drainage of abscess Laser Assisted Uvulopaletoplasty (LAUP) This laser is effective for cutting, ablating, coagulating and removing oropharangeal soft tissue that has been diagnosed as anatomically abnormal or naturally occurring hypertrophic which has been identified and confirmed as being associated with chroninc palatal snoring. Leukoplakia Operculectomy Oral papillectomies Pulpotomy Pulpotomy as an adjunct to root canal therapy Reduction of gingival hypertrophy Reduction of bacterial level (decontamination) and inflammation Soft tissue crown lengthening Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility) Treatment of aphthous ulcers Vestibuloplasty

#### Cautions and Contraindications:

All clinical procedures performed with Twilight™ must be subjected to the same clinical judgement 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, lung disease, bleeding disorders, sleep apnea or an immune system deficiency. Medical clearance from patient's physician is advisable when doubt exists regarding treatment.

#### Substantial Equivalence:

There are no unique applications, indications, materials or specifications presented herein. Twilight™ is identical to several other diode laser systems cleared by the FDA. Equivalent devices include: Premier, Aurora™(K954316), American Dental
Technologies, PulseMaster™ (K972325) and Dentek, LD-15 ™ (K974057) for general dental soft tissue applications, Premier, Aurora™ (K981379) for pulpotomy and American Dental Technologies, PulseMaster™ (K961269) and Premier, Aurora™ (K974586) for sulcular debridement.

#### Conclusion:

Twilight™ is substantially equivalent to several available, established dental diode laser products. Twilight™ performs through the same mechanism as other diode laser technologies.

· Evidence of equivalence has been demonstrated through:

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- Equivalent performance specifications
- Promotional materials for equivalent systems
- Equivalent intended uses

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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SEP 1 0 1999

Ms. Ioana M. Rizoiu Vice President, Clinical Research and Development BIOLASE Technology, Inc. 981 Calle Amanecer San Clemente, California 92673

K991994 Re: Trade Name: TwilightTM Regulatory Class: II Product Code: GEX Dated: June 11, 1999 Received: June 14, 1999 ·

Dear Ms. Rizoiu:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Ouality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2 - Ms. Ioana M. Rizoiu

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DUPLICATE

K 99 1994/K²

Page 1 of 3

510(k) Number : K991994

Device Name:

Twilight™

Indications for Use:

# Ear, Nose and Throat and Oral Surgery:

Hemostasis, incision, excision, ablation and vaporization of tissues from the ear, nose, throat and adjacent areas, including soft tissue in the oral cavity. Examples:

Removal of beningn lesions from ear, nose and throat. Excision and vaporization of vocal cord nodules and polyps. Incision and excision of carcinoma in-situ. Ablation and vaporization of kyperkeratosis. Excision of carcinoma of the larynx. Laryngeal papillomectomy. Excision and vaporization of herpes simplex I and II.

#### Arthroscopy:

Hemostasis, incision, excision, vaporization and ablation of joint tissues during arthroscopic surgery.

Examples:

Menisectomy Synovectomy Chondromalacia

#### Gastroenterology:

Hemostasis, incision, excision and vaporization of tissue in the upper and lower gastrointestinal tracts via endoscopy. Examples:

Hemostasis of upper and lower GI bleeding Excision and vaporization of colorectal carcinoma Excision of polyps

# General Surgery, Dermatology & Plastic Surgery, and Podiatry:

510(k) Number

Excision, ablation, vaporization and photocoagulation of skin lesions, hemostasis, incision, excision, vaporization, ablation and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissue and dermabrasion. Examples:

24 Aug 99 13 5

| Matrixectomy |
|--------------------------------------------|
| Excision of neuromas |
| Excision of periungual and subungual warts |
| Excision of plantar warts |
| Excision of Keloids |
| Liver resection |
| Excision of cutaneous lesions |
| Hemorrhoidectomy |
| Appendectomy |

(Division Sign-Off)
Division of General Restorative Devices K99199

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#### Page 2 of 3

General Surgery, Dermatology & Plastic Surgery, and Podiatry (continues): Examples:

Debridement of decubitus ulcer Hepatobiliary Mastectomy Dermabrasion Vaporization & hemostasis of capillary hemangioma Excision, vaporization & hemostasis of abdominal tumors Excision, vaporization & hemostasis of rectal pathology Pilonidal cystectomy Herniorraphy Adhesiolysis Parathyroidectomy Laparoscopic cholecystecomy Thyroidectomy Resection of organs

#### GI/GU:

Excision, vaporization, and hemostasis of abdominal and rectal tissues. Examples:

> Hemorrhoidectomy Excision, vaporization, and hemostasis of rectal pathology Excision, vaporization, and hemostasis of abdominal tumors

#### Gynecology:

Ablation, excision, hemostasis and vaporization of tissue. Examples:

> Endometrial ablation Excision or vaporization of condylomata acuminata Vaporization of CIN (cervical intraepithelial neoplasia) Cervical conization Menorrhagia

#### Neurosurgery:

Hemostasis of tissue. Example:

Hemostasis in conjunction with meningiomas

#### Ophthalmology:

Retinal photocoagulation Diabetic retinopathy

Signature

(Division Sign Off) Division of General Restorative Devices K 9 9 199 9 510(k) Number

#### Pulmonary Surgery:

Hemostasis, vaporization, and excision of tissue. Examples:

Tracheobronchial malignancy or stricture

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Page 3 of 3

# Pulmonary Surgery (continues):

Hemostasis, vaporization, and excision of tissue. Examples:

Benign and malignant pulmonary obstruction

Urology: Hemostasis, vaporization and excision of tissues. Examples:

> Vaporization of urethral tumors Release of urethral stricture Removal of bladder neck obstruction Excision and vaporization of condyloma Lesions of external genitalia.

> > Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OL

Over-The-Counter-Use _

pcoelle

(Division Sigo-Off)
Division of General Restorative Devices
510(k) Number ***_****_*K991994