The InPulse Laser 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 InPulse Laser is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).

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

Oropharangeal/ Dental Surgery Indicated for:

Abscess incision and drainage
Aphthous ulcers treatment
Biopsies, excisional and incisional
Crown lengthening
Exposure of unerupted I partially erupted teeth
Fibroma removal
Frenectomy
Frenotomy
Gingival incision and excision
Gingivectomy
Gingivoplasty
Hemostasis
Implant removal
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, 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 (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 InPulse Laser 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)
LCD screen user interface permitting selection of treatment emission when the footswitch is depressed and a fiber optic is properly attached):
1064 nm treatment laser (solid state Nd:YAG laser rod) with flashlamp and associated light regulation components and electronics;
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 noncontactuse to direct and control the placement of the laser beam) at the treatment location. The Guide tipattaches 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:
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;
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 is a 510(k) summary for the InPulse Laser, seeking substantial equivalence to a predicate device (K093547). This type of submission generally focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than proving performance against specific acceptance criteria through novel clinical studies.

Therefore, the document does not contain the detailed clinical study information typically found when a device needs to demonstrate its own performance against set acceptance criteria. Instead, it relies on the comparison of technological characteristics and identical indications for use to the predicate device.

Here's an analysis based on the provided text, addressing your points where possible, and noting where information is not present:

Description of Acceptance Criteria and Study to Prove Device Meets Them:

The InPulse Laser's acceptance criteria are implicitly defined by its substantial equivalence to the predicate device, the PinPointe FootLaser (K093547). The study demonstrating this substantial equivalence is a comparison of technological characteristics and identical indications for use. No formal clinical studies with specific acceptance criteria are reported for the InPulse Laser itself in this 510(k) summary, as its performance is assumed to be equivalent to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Since the submission is based on substantial equivalence, the "acceptance criteria" are the characteristics of the predicate device. The "reported device performance" is the InPulse Laser's matching of these characteristics.

Characteristic	Acceptance Criteria (Predicate: K093547 PinPointe FootLaser)	Reported Device Performance (InPulse Laser)
Product Code	General & Plastic Surgery	General & Plastic Surgery
Regulation	GEX, 21 CFR 878.4810	GEX, 21 CFR 878.4810
Intended Use	Intended for use in dermatologic and general surgical procedures	Intended for use in dermatologic and general surgical procedures
Indications for Use	See K093547 (Extensive list including Podiatry, Dermatology, Oropharyngeal/Dental, General, and Endonasal Surgery)	Exactly the same as K093547
Wavelength	1064nm	1064nm
Aiming beam	630-680 nm (< 2.5 mW)	630-680 nm (< 2.5 mW)
Power Watts	6W, 30W, 100W	6W, 30W, 100W
Pulse Duration (usec)	100-700 (6W), 350-3000 (30W), 350-3000 (100W)	100-700 (6W), 350-3000 (30W), 350-3000 (100W)
Energy per pulse (mJ)	20-200 (6W), 20-1000 (6W), 20-3500 (100W)	20-200 (6W), 20-1000 (6W), 20-3500 (100W)
Output Mode	Pulsed, multi mode	Pulsed, multi mode
Repetition rate	5-100Hz	5-100Hz
Laser media	Flashlamp pumped, solid state laser rod	Flashlamp pumped, solid state laser rod
User interface	Push button panel	LCD screen
Laser activation	Footswitch	Footswitch
Delivery devices, how supplied	Non-sterile, reusable, cleanable, sterilizable	Non-sterile, reusable, cleanable, sterilizable
Electrical requirements	90-130 VAC, 50/60 Hz; 200-240 VAC, 50/60 Hz	90-130 VAC, 50/60 Hz; 200-240 VAC, 50/60 Hz

Note on User Interface: The only noted difference is the user interface (LCD screen for InPulse Laser vs. Push button panel for predicate). The FDA's substantial equivalence determination implies this difference does not raise new questions of safety or effectiveness.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not applicable. No "test set" in the context of clinical data is reported in this 510(k) summary. The submission relies on comparative technological characteristics and identical indications for use.
Data Provenance: Not applicable. No clinical data is presented for the InPulse Laser in this document. The statement "No clinical data was needed for these indications. They are identical to those on K093547" explicitly clarifies this.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided. There was no "test set" requiring expert ground truth in this substantial equivalence submission.

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

This information is not applicable and not provided. There was no "test set" requiring adjudication in this substantial equivalence submission.

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 information is not applicable and not provided. The InPulse Laser is a surgical laser device, not an AI-assisted diagnostic or interpretive tool, and no MRMC study was conducted or reported.

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

This information is not applicable and not provided. The InPulse Laser is a physical medical device, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not applicable. No new ground truth was established for the InPulse Laser itself in this substantial equivalence submission. The ground truth for the safety and effectiveness of the predicate device would have been established during its own clearance process, but that information is not part of this document.

8. The sample size for the training set

This information is not applicable. No new training set for an algorithm was used or reported in this substantial equivalence submission.

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

This information is not applicable. No new training set for an algorithm was used or reported in this substantial equivalence submission.

Summary

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

Section 8 - Special 510(k) Summary

JUL 1 8 2013

I. General Information

Submitter:

Incisive Inc.

Contact Person:

Michael Yessik

myessik@gmail.com

510-669-9401

Summary Preparation Date: June 11, 2013

II. Names

Device Name(s): InPulse Laser

Primary Classification Name(s): Electrosurgical cutting and coagulation device and accessories

III. Predicate Devices

K093547 PinPointe FootLaser and Accessories .

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

IV. Product Description

The InPulse Laser 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) ●
LCD screen user interface permitting selection of treatment .
emission when the footswitch is depressed and a fiber optic is properly .
. attached):
. 1064 nm treatment laser (solid state Nd:YAG laser rod) with flashlamp and associated light regulation components and electronics;
. 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 noncontactuse to direct and . control the placement of the laser beam) at the treatment location. The Guide tipattaches 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:
- 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;
- . 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;

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

Optical Fiber Cleaver (carbide wedge, ceramic, or equivalent scribe for cleaving the . optical fibers).

V. Indications for Use

Indications for Use (same as K093547):

Podiatry

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

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

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

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

Oropharangeal/ Dental Surgery Indicated for:

. Abscess incision and drainage
. Aphthous ulcers treatment
. Biopsies, excisional and incisional
. Crown lengthening
Exposure of unerupted I partially erupted teeth .
Fibroma removal •
. Frenectomy
Frenotomy .
Gingival incision and excision .
Gingivectomy .
. Gingivoplasty
. Hemostasis
Implant removal .
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, 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 .

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

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 .

No clinical data was needed for these indications. They are identical to those on K093547.

VI. Summary of Technological Characteristics

The technological characteristics of the InPulse Laser are substantially equivalent to those of the predicate device.

		K093547
Characteristic	InPulse Laser	PinPointe FootLaser
Product Code	General & Plastic Surgery	General & Plastic Surgery
Regulation	• GEX, 21 CFR 878.4810	• GEX, 21 CFR 878.4810
Intended Use	Intended for use in dermatologic and general surgical procedures	Intended for use in dermatologic and general surgical procedures
Indications for Use	Exactly the same as K093547	See K093547
Wavelength	1064nm	1064nm
Aiming beam	630-680 nm (< 2.5 mW)	630-680 nm (< 2.5 mW)
Power Watts	6W, 30W, 100W	6W, 30W, 100W
Pulse Duration (usec)	100-700 (6W), 350-3000(30W), 350-3000 (100W)	100-700 (6W), 350-3000(30W), 350-3000 (100W)

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

		K093547
Characteristic	InPulse Laser	PinPointe FootLaser
Energy per pulse (mJ)	20-200 (6W), 20-1000 (6W), 20-3500 (100W)	20-200 (6W), 20-1000 (6W), 20-3500 (100W)
Output Mode	Pulsed, multi mode	Pulsed, multi mode
Repetitionrate	5-100Hz	5-100Hz
Laser media	Flashlamp pumped, solid state laser rod	Flashlamp pumped, solid state laser rod
User interface	LCD screen	Push button panel
Laseractivation	footswitch	footswitch
Delivery devices, how supplied	Non-sterile, reusable, cleanable, sterilizable	Non-sterile, reusable, cleanable, sterilizable
Electricalrequirements	90-130 VAC, 50/60 Hz200-240 VAC, 50/60 Hz	90-130 VAC, 50/60 Hz200-240 VAC, 50/60 Hz

Safety and Effectiveness Information VII.

The review of the indications for use and technical characteristics provided demonstrates that the InPulse Laser is substantially equivalent to the predicate device and is safe and effective for use for the various indications for use stated.

VIII. Conclusion

The InPulse Laser was found to be substantially equivalent to the predicate device.

The InPulse Laser shares identical indications for use, similar design features, and functional features with, and thus are substantially equivalent to, the predicate device.

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

Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The logo is in black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

July 18, 2013

Incisive, Inc. % Ms. Kathy Maynor Regulatory Consultant 26 Rebecca Court Homosassa, Florida 34446

Re: K131805

Trade/Device Name: InPulse Laser 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: June 11, 2013 Received: June 19, 2013

Dear Ms. Maynor:

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. Drue, 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. Ilsting 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

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

Page 2 - Ms. Kathy Maynor

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 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.lda.gov/AboutfDA/CentersOffices/CDRH/CDRHOffices/nem115809.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 Pari 803). please go to

http://www.fda.gov/MedicalDevices/Sufety/Reportal?roblem/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 number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincercly yours,

Mark N. Melkerson - S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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

Indications for Use Statement

510(k) Number (if known):

Device Name: InPulse Laser

Indications for Use (same as K093547):

The InPulse Laser™ and the delivery accessories that are used with them are intended for use in surgical procedures involving open, laparoscopic ablation, vaporization, vaporization, excision, incision, and coagulation of soft tissue in the medical specialties of general and cosmetic dentistry, otolaryngology IENT 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

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

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

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

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

ト Windows Friend on the Live Man Comment of the United on the United on the Man

Joshua C. Nipper -S

K131805

Page 1 of 4

(Division Sign-Off)

Division of Surgical Devices

510(k) Number K131805

Premarket Notification Special 510(k) Submission Incisive Inc. InPulse Laser

Section 7 Page 2 of 5

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

Indications for Use Statement (continued)

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: InPulse Laser

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 .
. 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 I partially erupted teeth .
Fibromfi removal .
Frenectomy .
Frenotomy .
Gingival incision and excision .
Gingivectomy ●
Gingivoplasty .

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 OF NEEDED)

の 100 m (1) 2006 m (1) 2007 m (1) 2007 m (1) 2007 m (100 m (100 m (100 m ) 200 m (100 m (100 m ) (100 m (100 m (100 m (100 m (100 m ) (100 m (100 m (100 m (100 m (100 m (10

Concurrence of CDRH, Office of Device Evaluation (ODE)

Joshua C. Nipper -S

(Division Sign-Off)	K131805
Division of Surgical Devices
510(k) Number K131805	Page 2 of 4

Premarket Notification Special 510(k) Submission Incisive Inc. InPulse Laser

Section 7 Page 3 of 5

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

Indications for Use Statement (continued)

510(k) Number (if known):

Device Name: InPulse Laser

Oropharangeal/ Dental Surgery- Continued Indicated for:

. Hemostasis
Implant removal .
. 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 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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Joshua C. Nipper -S

(Division Sign-Off)

Division of Surgical Devices

510(k) Number K131805

K131805

Page 3 of _ 4

Premarket Notification Special 510(k) Submission Incisive Inc. InPulse Laser

Section 7 Page 4 of 5

{11}------------------------------------------------

510(k) Number (if known):

Device Name: InPulse Laser

Indications for Use- Continued:

General Surgery- Continued Indicated for:

Pilonidal cystectomy . Pancreatectomy Resection oflipoma 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 .

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Joshua C. Nipper -S

(Division Sign-Off)

Division of Surgical Devices

510{k} Number K131805

K131805

Page 4 of _4

Premarket Notification Special 510(k) Submission Incisive Inc. InPulse Laser

Section 7 Page 5 of 5

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.