The PinPointe™ FootLaser™ and the delivery accessories that are used with them are intended for use in surgical procedures involving open, laparoscopic and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue in the medical specialties of general and cosmetic dentistry, otolaryngology/ENT surgery, and dermatology & plastic surgery including intraoral soft tissue dental surgery, oral maxillo-facial and cosmetic surgery, general surgery, E.N.T. surgery, podiatry, and dermatology and plastic surgery.

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

Matrixectomy
Periungual and subungual warts
Plantar warts
Radical nail excision
Neuromas

The PinPointe™ FootLaser™ is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).

Dermatology and plastic surgery (ablation, vaporization, incision, 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

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
Hemostasis
Implant recovery
Lesion (tumor) removal
Leukoplakia
Operculectomy
Oral papillectomy
Pulpotomy
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
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

Device Description

The PinPointe™ FootLaser™ is comprised of the following main components:

Main console containing the major electrical components, including:
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;
Delivery device fiber-optic connector port;
Remote interlock connector (External door interlock connector);
Connector ports for the footswitch and power cord;
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;
Guide Tip -With Standoff: Reusable, cleanable, tip is provided for 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:
A Reusable, cleanable, sterilizable optical fibers (range of Optical Fibers -200 - 1000 um diameter) provided non-sterile, clean and ready for sterilization (steam autoclave).
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;
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 location. The handpiece tips attach to the end of the handpiece. The optical fiber is threaded through both the handpiece and the handpiece tip:
Accessories:
Safety Glasses
Tools:
Optical Fiber Striper;
Optical Fiber Cleaver (carbide wedge, ceramic, or equivalent scribe for cleaving the optical fibers).

AI/ML Overview

The provided document, a 510(k) summary for the PinPointe™ FootLaser™, discusses the device's indications for use and substantial equivalence to predicate devices. It states that the "safety and effectiveness... was demonstrated in clinical studies" for the temporary increase of clear nail in patients with onychomycosis, but it does not provide detailed acceptance criteria or present the results of those studies in a structured format as requested. Therefore, I cannot fully answer the request based solely on the provided text.

Specifically, the document does not include:

A table of acceptance criteria and reported device performance.
Sample sizes used for test sets.
Data provenance for test sets.
Number of experts used to establish ground truth or their qualifications.
Adjudication methods.
Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or effect sizes of AI assistance.
Standalone (algorithm-only) performance.
Type of ground truth used (beyond implying clinical outcomes related to "clear nail").
Sample size for the training set.
How ground truth for the training set was established.

The document focuses on establishing substantial equivalence to predicate devices based on technological characteristics and a general statement about clinical studies for one specific indication.

Therefore, for the relevant section (onychomycosis), here is what can be extracted, and what cannot be provided:

Device Indication of Interest: Temporary increase of clear nail in patients with onychomycosis.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Explicitly Stated in Document)	Reported Device Performance (Explicitly Stated in Document)
Not explicitly stated in the document	Demonstrated "temporary increase of clear nail at 6 and 12 months following treatment in patients with onychomycosis"

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified in the document.
Data Provenance: The document only states that "clinical studies" were conducted. No information about country of origin or whether they were retrospective/prospective is provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not specified in the document.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not specified in the document.

5. 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:

This device is a laser system, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this device and is not mentioned in the document.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This device is a laser system for treatment, not a standalone diagnostic algorithm. This metric is not applicable and is not mentioned in the document.

7. The type of ground truth used:

Based on the indication, the ground truth would likely be clinical assessment of clear nail growth at 6 and 12 months post-treatment, presumably by a clinician. However, the document does not explicitly state the methodology for establishing this ground truth (e.g., objective measurements, subjective ratings by clinicians, etc.).

8. The sample size for the training set:

Not applicable as this is a medical device, not a machine learning algorithm that requires a training set in the conventional sense. The "clinical studies" mentioned would be analogous to a clinical trial, but details are not provided.

9. How the ground truth for the training set was established:

Not applicable for the reasons stated in point 8.

Summary

{0}------------------------------------------------

K093)'45

CONFIDENTIAL

lncisive

Section 5 - 510(k) Summary

I. General Information

OCT 1 5 2010

Submitter:

Incisive, Inc. 3095 Richmond Parkway, Suite 213 Richmond, CA 94806 Tel: 510-669-9401

Contact Person:

Summary Preparation Date:

Chief Executive Officer, Incisive, Inc October 13, 2010

Michael Yessik, PhD

giee
Inc.

II. Names

Trade Name(s):

PinPointe™ FootLaser™ (and delivery device accessories)

Common Name(s):

Laser Powered Surgical Instruments

Primary Classification Names:

Laser Powered Surgical Instruments (and Accessories) (21 CFR Part 878.4810, Product Code GEX)

III. Predicate Devices

. Incisive Family of InPulse Nd: Y AG Lasers (K083215);
PathoLase Family of PinPointe™ and PinPointe™ FootLaser™ Nd:YAG Lasers . (K083616).

IV. Product Description

The PinPointe™ FootLaser™ is comprised of the following main components:

Main console containing the major electrical components, including:
- Control/ Display Panel with the: A
  - . 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;
- 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); A

{1}------------------------------------------------

CONFIDENTIAL

. Footswitch:
A

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;

Guide Tip -With Standoff: Reusable, cleanable, tip is provided for minimal-contact with intact skin/ tissue to direct and control the placement of the laser beam at the treatment The Guide tip attaches to the end of the location. The optical fiber is threaded through the handpiece. handpiece and fits securely into the bore of the Guide tip;
Delivery Devices for Contact with Breached Surfaces:

109354

A Reusable, cleanable, sterilizable optical fibers (range of Optical Fibers -200 - 1000 um diameter) provided non-sterile, clean and ready for sterilization (steam autoclave).
- Reusable, cleanable, sterilizable handpieces (large and Handpieces 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;
Handpiece Tips . Disposable single-use tips are provided in straight and A 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: ●
- Safety Glasses
Tools: ●
- Optical Fiber Striper; A
- A Optical Fiber Cleaver (carbide wedge, ceramic, or equivalent scribe for cleaving the optical fibers).

V. Indications for Use

The PinPointe™ FootLaser™ and the delivery accessories that are used with them are intended for use in surgical procedures involving open, laparoscopic and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue in the medical specialties of general and cosmetic dentistry, otolaryngology/ENT surgery, and dermatology & plastic surgery including intraoral soft tissue dental surgery, oral maxillofacial and cosmetic surgery, general surgery, E.N.T. surgery, podiatry, and dermatology and plastic surgery.

{2}------------------------------------------------

Podiatry

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

. .

. Matrixectomy
. Radical nail excision
Periungual and subungual warts .

1693541

Plantar warts .
Neuromas ●
The PinPointe™ FootLaser™ is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).

Dermatology and Plastic Surgery

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

. Lesions of skin and subcutaneous tissue
. Telangiectasia
- Port wine lesions
Spider veins �
Hemangiomas 0

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 ●
Hemostasis .
. Implant recovery
Lesion (tumor) removal .
Leukoplakia .
Operculectomy ●
Oral papillectomy .

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
Thyroidectomy -
Removal of lesions
-Removal of polyps
Parathyroidectomy -
Removal of tumors -
Pulpotomy ●
Plantar warts

Removal of tattoos

Treatment of keloids

. Pulpotomy as adjunct to root canal therapy
Periungual and subungual warts

Debridement of decubitus ulcer

Removal of filling material such as . gutta percha or resin as adjunct treatment during root canal retreatment
. 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

{3}------------------------------------------------

CONFIDENTIAL

Pilonidal cystectomy
Pancreatectomy -
Resection of lipoma -
Splenectomy "
Pelvic adhesiolysis -
Hemorrhoidectomy -
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

The safety and effectiveness of the PinPointe™ FootLaser™ for use for the temporary increase of clear nail in patients with onychomycosis was demonstrated in clinical studies.

VI. Summary of Technological Characteristics

The technological characteristics of the PinPointe™ FootLaser™ are identical to those of the predicate devices.

Characteristic	K093547 - PinPointe™FootLaser™ and DeliveryDevices; PinPointe USA, Inc.			K083616 - PathoLase Family ofPinPointe™ and PinPointe™FootLaser™ Lasers; PathoLase,Inc.			K0832153 - Incisive Family ofInPulse Nd:YAG Lasers;Incisive, LLC
Wavelength	1064 nm			1064 nm			1064 nm
Aiming Beam	630-680 nm (≤ 2.5 mW)			630-680 nm (≤ 2.5 mW)			630-680 nm (≤ 2.5 mW)
Model	6 W	30 W	100 W	6 W	30 W	100 W	6 W	30 W	100 W
Energy Per Pulse(mJ)	20-200	20-1000	20 - 3500	20-200	20-1000	20 - 3500	20-200	20-1000	20 - 3500
Power (Watts)	≤ 6	≤ 30	≤ 100	≤ 6	≤ 30	≤ 100	≤ 6	≤ 30	≤ 100
Pulse Duration(μsec)	100 - 700	350 - 3000	350 - 3000	100 - 3000			100 - 700	350 - 3000	350 - 3000
Output Mode	Pulsed, Multi-Mode			Pulsed, Multi-Mode			Pulsed, Multi-Mode
Repetition Rate	5 - 100 Hz			5 - 100 Hz			5-100 Hz
Laser Media	Flashlamp-Pumped Solid StateLaser Rod			Flashlamp-Pumped Solid StateLaser Rod			Flashlamp-Pumped Solid StateLaser Rod
User Interface	Push-button control panel			LCD Color touch screen			Push-button control panel
Laser Activation	Footswitch			Footswitch			Footswitch
Delivery Devices• How supplied	• Non-sterile, reusable,cleanable, sterilizable			• Non-sterile, reusable, cleanable,sterilizable			• Non-sterile, reusable, cleanable,sterilizable
SystemDimensions	32" x 13" x 14" (H x W x D)			32" x 13" x 14" (H x W x D)			32" x 13" x 14" (H x W x D)
System Weight	17.2 kg (38 lbs)			17.2 kg (38 lbs)			17.2 kg (38 lbs)
Electrical Reqs.	90-130 VAC, 50/60 Hz200-240 VAC, 50/60 Hz			90-130 VAC, 50/60 Hz200-240 VAC, 50/60 Hz			90-130 VAC, 50/60 Hz200-240 VAC, 50/60 Hz

S002-024-1 K093547

{4}------------------------------------------------

093)'45'

Clinical study demonstrated the safety and effectiveness of the PinPointe™ FootLaser™ for use for the temporary increase of clear nail at 6 and 12 months following treatment in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).

VIII. Safety and Effectiveness Information

The review of the indications for use, technical characteristics, and clinical study results provided demonstrates that the PinPointe™ FootLaser™ is substantially equivalent to the predicate devices and is safe and effective for use for the temporary increase of clear nail at 6 and 12 months following treatment in patients with onychomycosis.

IX. Conclusion

The PinPointe™ FootLaser™ was found to be substantially equivalent to the predicate devices.

The PinPointe™ FootLaser™ share identical indications for use, similar design features, and functional features with, and thus are substantially equivalent to, the predicate devices.

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or body. The symbol is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Incisive, Inc. % Ms. Anne Worden Regulatory Consultant 3637 Bernal Avenue Pleasanton, California 94566

OCT 15 2010

Re: K093545

Trade/Device Name: PinPointe FootLaser and Accessories 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: October 13, 2010 Received: October 14, 2010

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. 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

{6}------------------------------------------------

Page 2 - Ms. Anne Worden

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 martistal) device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (2) CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 100-1000.

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/ucm 1 1 8809.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". 21 CFR Preu 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/Safety/ReportaProblem/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 nomber (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Sincerely yours,

Mark N. Melkerson

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

Enclosure

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

Indications for Use Statement

510(k) Number (if known): K093545

Device Name: PinPointe™ FootLaser™

Indications for Use:

Podiatry

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

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

* Page 1 of 4 *

V 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)

Barbara Huening
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K093545

Premarket Notification, 510(k) Submission for: Incisive PinPointe™ FootLaserTM

Section 4: Indications for Use

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

Indications for Use Statement - Continued

510(k) Number (if known):	K093545
Device Name:	PinPointe™ FootLaser™

13 200
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 .
� Telangjectasia
Port wine lesions .
. Spider veins
Hemangiomas .
. Plantar warts
Periungual and subungual warts
. Removal of tattoos
. Debridement of decubitus ulcer
Treatment of keloids .

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 t
Gingivectomy .
Gingivoplasty �

Prescription Use > (Part 21 CFR 801 Subpart D) *** Page 2 of 4 *** AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

OCT 1 5 - 2010

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED).

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nil R+Daler for mxm

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

510(k) Number K093545

Page 2 of 4

Premarket Notification, 510(k) Submission for: Incisive PinPointe™ FootLaserTM

Section 4: Indications for Use

{9}------------------------------------------------

Indications for Use Statement - Continued

510(k) Number (if known): K093545

Device Name: PinPointeTM FootLaser™

Indications for Use - Continued:

Oropharangeal / Dental Surgery - Continued

Indicated for:

. Hemostasis
Implant recovery .
Lesion (tumor) removal .
. Leukoplakia
Operculectomy .
. Oral papillectomy
Pulpotomy .
. 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

V Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

*** Page 3 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)

Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K093545

Page 3 of 4

Premarket Notification, 510(k) Submission for: Incisive PinPointe™ FootLaserTM

Section 4: Indications for Use

{10}------------------------------------------------

Indications for Use Statement - Continued

510(k) Number (if known): K093545

Device Name: PinPointe™ FootLaser™

Indications for Use - Continued:

General Surgery - Continued

Indicated for:

Pilonidal cystectomy -
Pancreatectomy -
Resection of lipoma -
Splenectomy -
Pelvic adhesiolysis -
Hemorrhoidectomy -
Removal of lesions -
Thyroidectomy -
Removal of polyps -
Parathyroidectomy -
Removal of tumors ﺖ
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 .

*** 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)

Neutee Dryden forman

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

510(k) Number K093545

Page 4 of 4

Premarket Notification, 510(k) Submission for: Incisive PinPointe™ FootLaserTM

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.

lncisive

Section 5 - 510(k) Summary

I. General Information

II. Names

III. Predicate Devices

IV. Product Description

V. Indications for Use

Podiatry

Dermatology and Plastic Surgery

Oropharangeal / Dental Surgery

General Surgery

CONFIDENTIAL

Endonasal Surgery

VI. Summary of Technological Characteristics

VIII. Safety and Effectiveness Information

IX. Conclusion

Indications for Use Statement

Podiatry

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Oropharangeal / Dental Surgery

Indications for Use Statement - Continued

Device Name: PinPointeTM FootLaser™

Oropharangeal / Dental Surgery - Continued

General Surgery

Indications for Use Statement - Continued

Device Name: PinPointe™ FootLaser™

General Surgery - Continued

Endonasal Surgery

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

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