INPULSE LASER

K131805 · Incisive, Inc. · GEX · Jul 18, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K131805
• Device Name: INPULSE LASER
• Applicant: Incisive, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jul 18, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

InPulse Laser is a flashlamp-pumped, solid-state Nd:YAG laser system (1064 nm) with a 630-680 nm aiming beam. It delivers pulsed energy (5-100 Hz) to soft tissue via fiber-optic delivery devices, including reusable handpieces and tips for contact or non-contact use. The system is operated by clinicians in surgical or clinical settings using a footswitch for activation and an LCD interface for parameter control (power, pulse duration, repetition rate). The laser energy enables precise ablation, vaporization, excision, incision, and coagulation of soft tissue. By providing a controlled surgical tool, the device facilitates various procedures across multiple specialties, including dentistry, podiatry, and general surgery, potentially reducing tissue trauma compared to traditional methods. The device includes safety features like a keyswitch, emergency stop, and remote interlock.

Clinical Evidence

No clinical data was needed for these indications as they are identical to those of the predicate device (K093547).

Technological Characteristics

Flashlamp-pumped Nd:YAG laser (1064 nm); 630-680 nm aiming beam (<2.5 mW). Power: 6W, 30W, 100W. Pulse duration: 100-3000 µsec. Repetition rate: 5-100 Hz. Delivery via fiber-optic handpieces/tips (reusable/disposable). Electrical: 90-130 VAC or 200-240 VAC, 50/60 Hz. User interface: LCD screen. Activation: Footswitch. Sterilization: Steam autoclave for reusable components.

Indications for Use

Indicated for patients requiring soft tissue ablation, vaporization, excision, incision, or coagulation in general surgery, dentistry, ENT, and dermatology/plastic surgery. Specific applications include podiatry (matrixectomy, warts, neuromas, onychomycosis for temporary increase of clear nail), dermatology (lesions, telangiectasia, tattoos, ulcers, keloids), dental/oropharyngeal procedures (abscesses, biopsies, gingivectomy, frenectomy, caries removal, sulcular debridement), and general/endonasal surgery (cholecystectomy, mastectomy, tonsillectomy, tumor removal).

Regulatory Classification

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.

Predicate Devices

• PinPointe FootLaser and Accessories (K093547)

Submission Summary (Full Text)

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## Section 8 - Special 510(k) Summary

JUL 1 8 2013

#### I. General Information

.

Submitter:

Incisive Inc.

Contact Person:

Michael Yessik

[e-mail]

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 .

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#### 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;

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- Optical Fiber Cleaver (carbide wedge, ceramic, or equivalent scribe for cleaving the . optical fibers).
#### V. Indications for Use

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 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

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

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

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### 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 .

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- 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) |

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| | | 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 |
| Repetition<br>rate | 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 |
| Laser<br>activation | footswitch | footswitch |
| Delivery devices, how supplied | Non-sterile, reusable, cleanable, sterilizable | Non-sterile, reusable, cleanable, sterilizable |
| Electrical<br>requirements | 90-130 VAC, 50/60 Hz<br>200-240 VAC, 50/60 Hz | 90-130 VAC, 50/60 Hz<br>200-240 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.

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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 [phone] or [phone] 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

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#### 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

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#### 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

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#### 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

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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