The Incisive Family of InPulse 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, excision, 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
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
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 periodonta 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:

Besions or turnors of the oral, nasal, glossal, pharyngeal & laryngeal tissues
Tonsillectomy
Adenoidectomy

Podiatry (ablation, vaporization, incision, 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, 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

Device Description

The Incisive Family of InPulse Nd:YAG Lasers are comprised of the following main components:
Main console containing the major electrical components, including:

Control/ Display Panel with the:
Keyswitch (that controls authorized acess to the laser sytem);
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 associaged 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);
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 (previously cleared in K011423, see below). 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 beamat the treatment location. The Guide tip attaches to the end of the handpiece (previously cleared in K011423, see below). 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):
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:
A Safety Glasses
Tools:
A Optical Fiber Striper:
A Optical Fiber Cleaver (carbide wedge, ceramic, or equivalent scribe for cleaving the optical fibers).

AI/ML Overview

This document is a 510(k) premarket notification for the Incisive Family of InPulse Nd:YAG Lasers. It is a submission to the FDA seeking clearance to market a medical device, demonstrating substantial equivalence to previously cleared devices, rather than a study proving the device meets specific acceptance criteria through clinical trials and performance metrics.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information is not applicable to this type of regulatory submission.

The document focuses on:

Device Description: What the device is and its components.
Predicate Devices: Identifying similar, legally marketed devices to establish a basis for comparison.
Rationale for Substantial Equivalence: Arguing that the new device is as safe and effective as the predicate devices, sharing similar indications for use, device operation, and technical/functional capabilities.
Indications for Use: Listing the specific medical procedures and specialties for which the laser is intended.

The FDA's review and approval (as indicated by the letter from Mark M. Melkerson) means they have determined the device is substantially equivalent to legally marketed predicate devices, subject to general controls, and can be marketed. This is a regulatory clearance based on equivalence, not a performance study against specific acceptance criteria.

Summary

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K063215

APR - 8 2009

Section 5 - 510(k) Summary

I. General Information

Submitter:

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

Contact Person:

Michael Yessik CEO, Incisive, LLC.

Summary Preparation Date: October 26, 2008

II. Names

Device Names:

Incisive Family of InPulse 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 Incisive Family of InPulse Nd:YAG Lasers are comprised of the following main components:

. Main console containing the major electrical components, including:

Control/ Display Panel with the: A
- Keyswitch (that controls authorized acess to the laser sytem); ●
- . 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 associaged light regulation components and electronics;
A 630 -680 nm (red) aiming beam diode laser;
Delivery device fiber-optic connector port; A
A Remote interlock connector (External door interlock connector);
- Connector ports for the footswitch and power cord:

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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 (previously cleared in K011423, see below). 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 beamat the treatment location. The Guide tip attaches to the end of the handpiece (previously cleared in K011423, see below). 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 -

Handpieces -

Reusable, cleanable, sterilizable optical fibers (range of 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:

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 Incisive Family of InPulse Nd: YAG Lasers share or similar indications for use, device operation, overall technical and functional capabilities, and therefore is substantially equivalent to the predicate devices.

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VI. Safety and Effectiveness Information

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

Conclusion VII.

The Incisive Family of InPulse Nd:YAG Lasers were found to be substantially equivalent to the predicate devices.

The Incisive Family of InPulse 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 seal of the U.S. Department of Health & Human Services. The seal features an abstract eagle design with three curved lines representing the bird's body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

APR - 8 2009

Re: K083215

Trade/Device Name: Incisive Family of InPulse Nd: YAG Lasers 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: March 23, 2009 Received: March 25, 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 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

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Page 2 - Ms. Anne Worden

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.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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.

Sincerely yours,

Mark M. Melkerson

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

Enclosure

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K083215 p. A. of 4

Indications for Use Statement - Continued

510(k) Number (if known):	K08. 3215
Device Name:	Incisive Family of InPulse 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:	✓	AND/OR	Over-The-Counter Use
-------------------	----------------------------------------------------	--------	----------------------

Pricese DO NOT WRITE BELOW THIS LINE-CONTINUE ON AND/OR CONTINUE CONSTITUTION OF CONTINUES PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Millerm

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

1 16 1

510(k) Number K08

Premarket Notification, 510(k) Submission for: Incisive Family of InPulse Nd: YAG Lasers

Page 1 of 4 : 2. 1.

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Indications for Use Statement - Continued

510(k) Number (if known): K08

Device Name: Incisive Family of InPulse 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 periodonta 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

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)

Premarket Notification, 510(k) Submission for: Incisive Family of InPulse Nd: YAG Lasers

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

Indications for Use Statement - Continued

510(k) Number (if known): K08

Device Name: Incisive Family of InPulse Nd: YAG Lasers

Indications for Use - Continued:

General Surgery - Continued

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:

Besions or turnors of the oral, nasal, glossal, pharyngeal & laryngeal tissues
Tonsillectomy
Adenoidectomy

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

Matrixectomy
Periungual and subungual warts
Plantar warts
Radical nail excision
Neuromas

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 IN NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Premarket Notification, 510(k) Submission for: Incisive Family of InPulse Nd: YAG Lasers

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

083215

Indications for Use Statement - Continued

510(k) Number (if known): K08

Device Name: Incisive Family of InPulse Nd:YAG Lasers

Indications for Use - Continued:

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

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)

Premarket Notification, 510(k) Submission for: Incisive Family of InPulse Nd: Y AG Lasers

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.