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 summary 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 Description

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text:

Acceptance Criteria and Reported Device Performance

The document does not explicitly define quantitative acceptance criteria in terms of specific performance metrics (like accuracy, sensitivity, specificity, etc.) for the StarLite 2006. Instead, the primary "acceptance criterion" appears to be substantial equivalence to legally marketed predicate devices, meaning it functions in the same way and uses the same materials and principles.

Therefore, the table will reflect this qualitative assessment of equivalence, rather than specific performance numbers.

Acceptance Criterion (Implicit)	Reported Device Performance
Functional Equivalence: Device functions in the same way as predicate devices.	"The StarLite functions in exactly the same way as fiber optics included with the above [predicate] laser systems.""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.""The StarLite 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."
Material Equivalence: Device uses the same type of materials as predicate devices.	"The materials used in the StarLite are the same in and are the functional equivalent as those used in the above cleared laser systems."
Compatibility: Device is compatible with existing handpieces and laser systems.	"The protective outside buffer or jacket is compatible with all handpieces designed for this fiber type.""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 laser fibers including 200, 300, 400 and 600 micron diameters."
Sterilization: Device can be sterilized to a specified level.	"standard autoclave flash processing at 270 degrees F. for 30 minutes will produce a sterility assurance level (SAL) of 10^-6."
Safety: Device complies with relevant performance standards and controls.	"Various voluntary performance standards are utilized. Voluntary standards include Standard Operating Procedures, vendor and process certification and qualification procedures." "LDI, Inc. is in compliance with special controls as outlined in 21 CFR Part 1040 - Performance Standards for Light-Emitting Products."
Indications for Use: Device can be used for the same indications as the laser system it is attached to.	"The StarLite is cleared for the same cleared indications of use as the laser system to which it is attached.""The StarLite will become an integral part of the laser system and by default be cleared for the same exact indications and procedures as the laser it is deployed on."

Here's an analysis of the study related information, based on the provided text:

Sample size used for the test set and the data provenance:
- The document does not describe a test set, a specific study with a sample size, or data provenance in the context of typical device performance evaluation (e.g., clinical trials, bench testing with a defined set of samples).
- The focus is on demonstrating "substantial equivalence" through descriptive comparisons to predicate devices and adherence to design principles rather than empirical performance testing against a specific dataset.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no mention of a test set, ground truth, or experts establishing such ground truth.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No test set or adjudication method is described.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. The device is a laser optical fiber, not an AI or diagnostic imaging device. No MRMC study was performed or mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device is a physical component (laser fiber), not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. No ground truth is mentioned in the context of device performance evaluation. The "ground truth" for this submission is implicitly the established functionality and safety of the predicate devices and general industry standards for laser fiber optics.
The sample size for the training set:
- Not applicable. The device is a physical component, not a learning algorithm or AI. There is no concept of a "training set" for this product submission.
How the ground truth for the training set was established:
- Not applicable. As there is no training set, this question is not relevant.

Summary

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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
1. 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

1. 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
1. ADT Diolase K961269
1. 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.

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

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

1. 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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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.

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)

ਾਤ

Over-The-Counter Use

bare Indus for MKM

and Neurological Devices

510(k) Number K052604

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.