The PathoLase Family of PinPointe™ and PinPointe™ FootLaser™ Nd:YAG Lasers and the delivery accessories that are used with them are intended for use in surgical procedures involving open, laparoscopic and endoscopic ablation, vaporization, incision, and coagulation of soft tissue in the medical specialties of general and cosmetic dentistry, otolaryngology/ENT surgery, and dermatology & plastic surgery including: Oropharangeal / Dental Surgery, General Surgery, Endonasal Surgery, Podiatry, and Dermatology and Plastic Surgery.

Device Description

The PathoLase Family of PinPointe™ and PinPointe™ FootLaser™ Nd:YAG Lasers are comprised of the following main components: Main console containing the major electrical components, including: A Control/ Display Panel, A 1064 nm treatment laser (solid state Nd: YAG laser rod) with flashlamp and associated light regulation components and electronics; A 630 -680 nm (red) aiming beam diode laser; A Delivery device fiber-optic connector port; A Remote interlock connector (External door interlock connector); A Connector ports for the footswitch and power cord; A Accessory holder (attached to the rear of the main console); Footswitch; Medical grade power cord; Delivery Devices for Non-Contact and Contact with Intact Skin/Tissue: Guide Tip -No Standoff, Guide Tip With Standoff; Delivery Devices for Contact with Breached Surfaces (Previously Cleared in K011423): Optical Fibers, Handpieces, Handpiece Tips; Accessories: Safety Glasses, Tools: Optical Fiber Striper, Optical Fiber Cleaver (carbide wedge, ceramic, or equivalent scribe for cleaving the optical fibers).

AI/ML Overview

This K083616 submission is for a Traditional 510(k) for PathoLase Family of PinPointe™ and PinPointe™ FootLaser™ Nd:YAG Lasers.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document (K083616) does not contain specific acceptance criteria or detailed device performance metrics in a manner typical for medical device studies evaluating diagnostic accuracy or algorithmic performance. This is a 510(k) summary for a laser device, and its primary purpose is to demonstrate substantial equivalence to predicate devices, not to present a rigorous performance study of a new diagnostic algorithm.

The core claim is that the device is "substantially equivalent" to existing predicate devices. This means that the device is considered as safe and effective as a legally marketed device without requiring a new PMA. The "performance" in this context is the general functionality and intended use, which is deemed equivalent to the predicates.

Acceptance Criteria (Implied)	Reported Device Performance
Substantial Equivalence to Predicate Devices (Lumenis VersaPulse PowerSuite, Incisive InPulse Dental Laser)	Shared "same or similar indications for use, device operation, overall technical and functional capabilities."
Safety Profile Equivalent to Predicates	Not explicitly detailed, but implied by substantial equivalence claim.
Effectiveness Profile Equivalent to Predicates	Not explicitly detailed, but implied by substantial equivalence claim.
Compliance with General Controls	Not detailed; this is an FDA requirement for all devices.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not applicable/not provided. This submission is for a laser surgical instrument, not a device that relies on a "test set" of data for performance evaluation in the way a diagnostic algorithm would.
Data Provenance: Not applicable/not provided for performance evaluation. The submission relies on a comparison to predicate devices and their established safety and effectiveness.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable/not provided. This type of expert assessment for ground truth is specific to studies evaluating diagnostic accuracy or image interpretation, which is not the nature of this device submission.

4. Adjudication Method for the Test Set:

Not applicable/not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

Not applicable/not provided. This is a laser surgical instrument, not an AI-powered diagnostic device that involves human readers or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable/not provided. The device is a surgical laser, not an algorithm.

7. The Type of Ground Truth Used:

Not applicable/not provided in the context of a "ground truth" for a performance study. The "truth" in this submission relies on the established safety and effectiveness of the predicate devices for their stated indications.

8. The Sample Size for the Training Set:

Not applicable/not provided. There is no AI algorithm being trained for this device.

9. How the Ground Truth for the Training Set Was Established:

Not applicable/not provided.

Summary of Device and Acceptance Criteria (from the provided text):

The PathoLase Family of PinPointe™ and PinPointe™ FootLaser™ Nd:YAG Lasers are 1064 nm Nd:YAG lasers intended for surgical procedures involving ablation, vaporization, incision, and coagulation of soft tissue across various medical specialties (general & cosmetic dentistry, ENT, dermatology & plastic surgery, general surgery, endonasal surgery, podiatry).

The acceptance criteria for this 510(k) submission are implicitly tied to the FDA's "substantial equivalence" determination. This means the device must demonstrate that it is as safe and effective as legally marketed predicate devices. The "study" to prove this is the comparison of the new device's characteristics and intended uses to those of the predicate devices.

The submission lists the following as proof of shared characteristics:

Identical indications for use (as extensively listed in the "Indications for Use" section).
Similar design features.
Similar functional features.
Similar device operation.
Similar overall technical and functional capabilities.

The FDA's decision to clear the device (K083616) on June 12, 2009, signifies that they found these comparisons sufficient to deem the PathoLase Family of PinPointe™ and PinPointe™ FootLaser™ Nd:YAG Lasers substantially equivalent to the identified predicate devices (Lumenis VersaPulse PowerSuite and Incisive InPulse Dental Laser).

Summary

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KO83616

JUN 1 2 2009

Section 5 - 510(k) Summary

I. General Information

Submitter:

PathoLase, Inc. 275 Airpark Boulevard Suite 500 Chico, CA 95973 Tel: 230-809-3800

Contact Person:

John Strisower Chairman & Chief Executive, PathoLase, Inc.

Summary Preparation Date: May 6, 2009

II. Names

Device Names:

PathoLase Family of PinPointe™ and PinPointe™ FootLaser™ Nd: Y AG Lasers (and delivery device accessories)

Primary Classification Names: . Laser Powered Surgical Instruments (and Accessories)

III. Predicate Devices

Modified Lumenis VersaPulse PowerSuite Holmium (Ho:YAG) and Dual . Wavelength (Ho:YAG) Nd:YAG) Surgical Lasers and Delivery Devices with Accessories - 2100 nm & 1064 nm (K011703)
Incisive InPulse Dental Laser 1064 nm (K011423). �

IV. Product Description

The PathoLase Family of PinPointe™ and PinPointe™ FootLaser™ Nd:YAG Lasers are comprised of the following main components:

. Main console containing the major electrical components, including:
- A Control/ Display Panel with the:
  - Keyswitch (that controls authorized access to the laser system); .
  - emergency Laser Stop button; .
  - Displays (laser emission indicator, average power, pulse energy, . repetition rate)
  - . Standby button (default mode when laser system turned on - places system into the Standby mode preventing laser emission).
  - Ready button (places system into the Ready mode allowing laser . emission when the footswitch is depressed and a fiber optic is properly attached);
  - A 1064 nm treatment laser (solid state Nd: YAG laser rod) with flashlamp and associated light regulation components and electronics;
  - A 630 -680 nm (red) aiming beam diode laser;
  - A Delivery device fiber-optic connector port;
- A Remote interlock connector (External door interlock connector);

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KOS 3616

A Connector ports for the footswitch and power cord;
A Accessory holder (attached to the rear of the main console);
. Footswitch:

Medical grade power cord;
Delivery Devices for Non-Contact and Contact with Intact Skin/Tissue:
- Guide Tip -No Standoff: Reusable, cleanable, tip is provided for noncontact use to direct and control the placement of the laser beam (free beam) at the treatment location. The Guide tip attaches to the end of the handpiece. The optical fiber is threaded through the handpiece and fits securely into the bore of the Guide tip;
- With Standoff: Reusable, cleanable, tip is provided for Guide Tip minimal-contact with intact skin/ tissue to direct and control the placement of the laser beam at the treatment location. The Guide tip attaches to the end of the handpiece. The optical fiber is threaded through the handpiece and fits securely into the bore of the Guide tip;
Delivery Devices for Contact with Breached Surfaces (Previously Cleared in K011423):
- A Optical Fibers -Reusable, cleanable, sterilizable optical fibers (range of 200 - 1000 um diameter) provided non-sterile, clean and ready for sterilization (steam autoclave).
  - Handpieces -Reusable, cleanable, sterilizable handpieces (large and small diameter shafts) provided non-sterile, clean and ready for sterilization (steam autoclave). The optical fiber is threaded through the handpiece and secured and held in place with the handpiece locking cap:
- A Handpiece Tips - Disposable single-use tips are provided in straight and curved configurations and are used to direct and control the placement of the optical fiber tip at the treatment The handpiece tips attach to the end of the location. handpiece. The optical fiber is threaded through both the handpiece and the handpiece tip;
Accessories: ●

A Safety Glasses
Tools: .
- A Optical Fiber Striper;
- A Optical Fiber Cleaver (carbide wedge, ceramic, or equivalent scribe for cleaving the optical fibers).

V. Rationale for Substantial Equivalence

The PathoLase Family of PinPointe™ and PinPointe™ FootLaser™ Nd:YAG Lasers share the same or similar indications for use, device operation, overall technical and functional capabilities, and therefore is substantially equivalent to the predicate devices.

VI. Safety and Effectiveness Information

The review of the indications for use and technical characteristics provided demonstrates that the PathoLase Family of PinPointe™ and PinPointe™ FootLaser™ Nd:YAG Lasers are substantially equivalent to the predicate devices.

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083616

VII. Conclusion

The PathoLase Family of PinPointe™ and PinPointe™ FootLaser™ Nd:YAG Lasers were found to be substantially equivalent to the predicate devices.

The PathoLase Family of PinPointe™ and PinPointe™ FootLaser™ Nd:YAG Lasers share identical indications for use, similar design features, and functional features with, and thus are substantially equivalent to, the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

PathoLase, Incorporated A L Voss Associates % Ms. Anne Worden 3637 Bernal Avenue Pleasanton, California 94566

JUN 1 2 2003

Re: K083616

Trade/Device Name: PathoLase Family of PinPointe™ and PinPointe™

FootLaser™ Nd:YAG Lasers

Regulation Number: 21 CFR 878.4810

Regulation Name: Lascr Surgical Instrument for Use In General And Plastic Surgery and In Dermatology

Regulatory Class: II Product Code: GEX Dated: May 6, 2009 Received: May 8, 2009

Dear Ms. Worden:

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 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

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Page 2-Ms. Worden

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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours

for
Mark N. Melkerson

Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K083616

Device Name: PathoLase Family of PinPointe™ and PinPointe™ FootLaser™ Nd: YAG Lasers

Indications for Use:

Oropharangeal / Dental Surgery

Indicated for:

� Abscess incision and drainage
Aphthous ulcers treatment .
Biopsies, excisional and incisional .
Crown lengthening .
Exposure of unerupted / partially erupted teeth
Fibroma removal
Frenectomy
Frenotomy
Gingival incision and excision
Gingivectomy
Gingivoplasty
Hemostatis
Implant recovery
- Lesion (tumor) removal
Leukoplakia
Operculectomy
Oral papillectomy
Pulpotomy

Prescription Use (Part 21 CFR 801 Subpart D) ** Page 1 of 4 * 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)

Nulke Odes Formen

(Division S (Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number

Page 1 of 4

Premarket Notification, 510(k) Submission for: PathoLase Family of PinPointe™ and PinPointe™ FootLaser™ Nd: YAG Lasers Section 4: Indications for Use

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510(k) Number (if known): K083616

Device Name: PathoLase Family of PinPointe™ and PinPointe™ FootLaser™ Nd: YAG Lasers

Indications for Use - Continued:

Oropharangeal / Dental Surgery - Continued

. Pulpotomy as adjunct to root canal therapy
Removal of filling material such as gutta percha or resin as adjunct treatment during root . canal re-treatment
Selective ablation of enamel (first degree) caries removal ●
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
Tissue retraction for impressions .
. Vestibuloplasty

General Surgery

Indicated for:

Open, laparoscopic, and endoscopic general surgery (ablation, vaporization, incision,
- excision, and-coagulation-of-soft-tissue) including: -
- Cholecystectomy
- Lymphadenectomy
- Mastectomy
- Partial nephrectomy
- Hepatectomy
- Pilonidal cystectomy
- Pancreatectomy
- Resection of lipoma
- Splenectomy
- Pelvic adhesiolysis
- Hemorrhoidectomy

Removal of lesions

Prescription Use V

AND/OR (Part 21 CFR 801 Subpart D)

*** Page 2 of 4 *** 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)

Neil K. Oslen Forman

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K083616

Page 2 of 4

Premarket Notification, 510(k) Submission for: PathoLase Family of PinPointe™ and PinPointe™ FootLaser™ Nd: YAG Lasers

Section 4: Indications for Use

{7}------------------------------------------------

510{k) Number (if known): K083616

Device Name: PathoLase Family of PinPointe™ and PinPointe™ FootLaser™ Nd:YAG Lasers

Indications for Use - Continued:

General Surgery - Continued

Thyroidectomy -
Removal of polyps
Parathyroidectomy
Removal of tumors
Herniorrhaphy
Tumor biopsy
Tonsillectomy
Debridement of decubitus ulcers
Appendectomy

Endonasal Surgery

Endonasal surgery (ablation, vaporization, incision, and coagulation of soft tissue) including:

Lesions or tumors of the oral, nasal, glossal, pharyngeal & laryngeal tissues ●
Tonsillectomy .
Adenoidectomy . ●

Podiatry

Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:

. Matrixectomy
Periungual and subungual warts .
Plantar warts
Radical nail excision
Neuromas

Page 3 of 4

Prescription Use (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)

Nul R.P. O'sada Firman

(Division Sign-C Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K083616

Page 3 of 4

Premarket Notification, 510(k) Submission for: PathoLase Family of PinPointe™ and PinPointe™ FootLaser™ Nd: YAG Lasers Section 4: Indications for Use

{8}------------------------------------------------

510(k) Number (if known): _ K083616

Device Name: PathoLase Family of PinPointe™ and PinPointe™ FootLaser™ Nd:YAG Lasers

Indications for Use - Continued:

Dermatology and Plastic Surgery

Dermatology and plastic surgery (ablation, vaporization, excision, and coagulation of soft tissue) including:

Lesions of skin and subcutaneous tissue �
Telangiectasia
Port wine lesions
Spider veins
Hemangiomas
Plantar warts
Periungual and subungual warts
Removal of tattoos
Debridement of decubitus ulcer
Treatment of keloids

*** Page 4 of 4 ***

Prescription Use (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)

Net Rf Ogden for mktm

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number

Page 4 of 4

Premarket Notification, 510(k) Submission for: PathoLase Family of PinPointe™ and PinPointe™ FootLaser™ Nd: YAG Lasers Section 4: Indications for Use

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.

JUN 1 2 2009

Section 5 - 510(k) Summary

I. General Information

II. Names

III. Predicate Devices

IV. Product Description

KOS 3616

V. Rationale for Substantial Equivalence

VI. Safety and Effectiveness Information

VII. Conclusion

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Oropharangeal / Dental Surgery

Oropharangeal / Dental Surgery - Continued

General Surgery

General Surgery - Continued

Endonasal Surgery

Podiatry

** Page 3 of 4 **

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dermatology and Plastic Surgery

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

Page 3 of 4