STARLITE 2006

K052604 · Laser Dental Innovations · GEX · Dec 16, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K052604
• Device Name: STARLITE 2006
• Applicant: Laser Dental Innovations
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Dec 16, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Starlite 2006 will be used with the following lasers for the excision, ablation, vaporization and hemostasis of soft tissue. Diolase ST produced by American Dental Technologies (810 Nm operating wavelength) Twilight produced by Biolase (810 Nm operating wavelength) Diodent produced by Hoya Con Bio (810 Nm operating wavelength) Softlase produced by Zap Lasers (810 Nm operating wavelength) Aurora produced by Premier Lasers (810 Nm operating wavelength) indications of use surnmary statement: The StarLite laser fiber optic can be used for all the of the lasers cited above as well as other diode soft tissue lasers operating using the same wavelengths. The StarLite will become an intergral part of the laser system and by default be cleared for the same exact indications and procedures as the laser it is deployed on.

Device Story

StarLite 2006 is an after-market fiber optic accessory for existing surgical diode laser systems. It functions as a delivery system (optical fiber and connector) to transmit laser energy from the source to the operative site. The device is designed for 'contact mode' operation, where the bare fiber is applied directly to soft tissue. It is compatible with various handpieces via a protective outer buffer/jacket. The device is used in clinical settings by healthcare providers performing soft tissue surgical procedures. It acts as a direct replacement for original equipment manufacturer (OEM) laser fibers. By delivering laser energy, it enables surgical procedures such as excision and hemostasis, providing a functional equivalent to OEM fibers without altering the laser beam's performance.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Fiber optic assembly including optical fiber and connector. Compatible with 200, 300, 400, and 600 micron diameter hard clad laser fibers. Features a protective outer buffer/jacket compatible with standard handpieces. Sterilization via autoclave flash processing (270°F for 30 minutes) to achieve a sterility assurance level (SAL) of 10^-6.

Indications for Use

Indicated for excision, ablation, vaporization, and hemostasis of soft tissue using compatible diode lasers (810 nm wavelength).

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

• Biolase Twilight (K991994)
• Premier Aurora (K992374)
• Zap Softlase (K021227)
• ADT Diolase (K961269)

Reference Devices

• Hoya Diodent

Submission Summary (Full Text)

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## DEC 1 6 2005

## Appendix IV

K 052604

### Summary of Safety &

### Effectiveness Information

| Summary of Safety and Effectiveness Information | StarLite 2006 |
|-------------------------------------------------|---------------|
| Section 510(k) Premarket Notification | Laser Optical |
| | Fiber |

Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92

- 1. Device Name:
Device trade Name: StarLite 2006 Common Name: Laser Accessory Classification Name: Laser Instrument, Surgical, Powered

- 2. Establishment Name & Registration Number:
Name: Laser Dental Innnovations Number: 3003610527

### Classification: 3. 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology 874,4500 Laser, ENT 874.4490 Laser, Otolarngology 874.4550 Laser, Surgical, Gynecological

- 4. Device Class: Class II for all requested indications Classification Panel: General and Plastic Surgery & others Product Codes: GEX
#### 5. Performance Standards:

Various voluntary performance standards are utilized. Voiuntary standards include Standard Operating Procedures , vendor and process certification and qualification procedures.

#### 6. Special Controls:

LDI, Inc. is in compliance with special controls as outlined in 21 CFR Part 1040 - Performance Standards for Light-Emitting Products. See 21 CFR §1040.10. Laser products.

## 7. Equivalent or Comparison Devices: (legally marketed)

- 1. Biolase Twilight: K991994
- 2 Premier Aurora: K992374
- 3 Zap Softlase: K021227
- 4. ADT Diolase K961269
- 5. Hoya Diodent

The Start ite the finctions in exactly the same way as fiber optios included with the above hase Systems Startlite uses the same type of connector, fiber and fiber rizes and does not channey the function or performance of the laser bearn. The materials used in the Shirlife are the same in are the functional equivalent as those used in the above cleared laser systems.

Starbore das

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### 8. Device Description:

Background. The starLite 2065 is an "after-market" accessory for use with an existing surgical laser system. The device is used as a complete system (optical fiber and connector) The StarLite 2006 IS used as a direct replacement for the laser optical fiber supplied as original equipment or the original equipment laser optical fiber.

One of the primary considerations when using a fiber-optically delivered surgical laser system is that the fiber is capable of delivering the maximum amount of energy the laser is set for minus a small connector loss.

Most fiber based laser systems include a handpiece that clasps or grips the laser fiber on its protective jacket. For this reason the laser fiber must have an outside coating capable of protecting the inner core.

Many procedures call for the use or application of a "bare fiber" to the operative tissue; the so called "contact mode" of operation.

The StarLice is designed using industry standard connectors and optical fiber. The components of this fiber optic assembly are the same as what is currently being used on cleared existing lasers cited above. The protective outside buffer or jacket is compatible with all handpieces designed for this fiber type.

The starLite laser fiber optic is intended for use with lasers that do various surgical procedures. The StarLite is universal in nature and is intended to be used on currently FDA cleared soft tissue lasers. The StarLite assembly is designed to accommodate hard clad faser fibers including 200, 300, 400 and 600 micron diameters.

#### ക് Cleared Indications for use:

The StarLite is cleared for the same cleared indications of use as the laser system to which it is attached.

#### 10. Applicant/ Sponser Name/ Address:

Laser Dental Innovations 745 Dubanski Drive San Jose, CA 95123 877-753-5054

#### 11. Company Contact:

Mr. Howard Feinberg Laser Dental Innovations 745 Dubanski Drive San Jose, CA 95123 877-753-5054

- 12. Submission Correspondent: Mr. Howard Feinberg
Laser Dental Innovations 745 Dubanski Drive San Jose, CA 95123 877-753-5054

#### 13. Sterification Information:

The laser optical liber may be storilized and/or re-sterilized until 1 meter remains. After cleaning and inspection, standard autoclave flash processing at 270 degrees F. for 30 minutes will produce n steality assurance level (SAL) of 10"

Maramada

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three wavy lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.

DEC 1 6 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Howard Feinberg Laser Dental Innovations 745 Dubanski Drive San Jose, California 95123

Re: K052604/S1 Trade/Device Name: StarLite® 2006 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 19, 2005 Received: October 21, 2005

Dear Mr. Feinberg:

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.

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); labeling (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.

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Page 2 - Mr. Feinberg

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Barbara Buchund
ter

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Statement of Intended Use:

Page 1

# 510(k) Number: N 052604-

Device Name: StarLite® 2006

### Indications for Use:

The Starlite 2006 will be used with the following lasers for the excision, ablation, vaporization and hemostasis of soft tissue.

Diolase ST produced by American Dental Technologies (810 Nm operating wavelength) Twilight produced by Biolase (810 Nm operating wavelength) Diodent produced by Hoya Con Bio (810 Nm operating wavelength) Softlase produced by Zap Lasers (810 Nm operating wavelength) Aurora produced by Premier Lasers (810 Nm operating wavelength)

indications of use surnmary statement: The StarLite laser fiber optic can be used for all the of the lasers cited above as well as other diode soft tissue lasers operating using the same wavelengths.

The StarLite will become an intergral part of the laser system and by default be cleared for the same exact indications and procedures as the laser it is deployed on.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801 109)

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Over-The-Counter Use

bare Indus for MKM

and Neurological Devices

**510(k) Number** K052604