K Number
K131805
Device Name
INPULSE LASER
Manufacturer
Date Cleared
2013-07-18

(29 days)

Product Code
Regulation Number
878.4810
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
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).
More Information

Not Found

No
The document describes a laser system for surgical procedures and does not mention any AI or ML components in its description or performance studies.

Yes
The "Intended Use / Indications for Use" section explicitly states that the device is for "surgical procedures" and lists various medical conditions and procedures it is intended to treat, such as "onycholysis," "warts," "telangiectasia," and "abscess incision and drainage," which are all therapeutic interventions.

No

The InPulse Laser is intended for surgical procedures involving ablation, vaporization, excision, incision, and coagulation of soft tissue. It is a therapeutic device, not a diagnostic one.

No

The device description clearly outlines numerous hardware components including a main console, laser components, delivery devices (fibers, handpieces, tips), and accessories. This is not a software-only device.

Based on the provided text, this device is not an In Vitro Diagnostic (IVD).

Here's why:

  • Intended Use: The intended use clearly describes the device as a surgical laser system used for procedures involving the ablation, vaporization, excision, incision, and coagulation of soft tissue in vivo (within the living body). IVDs are used to examine specimens in vitro (outside the living body), such as blood, urine, or tissue samples, to provide information for diagnosis, monitoring, or screening.
  • Device Description: The device description details a laser system with delivery accessories designed for direct application to tissue. This is consistent with a surgical device, not an IVD.
  • Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples, reagents, or any other components typically associated with IVD testing.

Therefore, the InPulse Laser is a surgical device, not an In Vitro Diagnostic.

N/A

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

GEX

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 noncontact use 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;
    • 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).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Soft tissue, nail, skin, subcutaneous tissue, oropharyngeal, dental, oral, nasal, glossal, pharyngeal, laryngeal.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K093547

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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.

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):

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

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
CharacteristicInPulse LaserPinPointe FootLaser
Product CodeGeneral & Plastic SurgeryGeneral & Plastic Surgery
Regulation• GEX, 21 CFR 878.4810• GEX, 21 CFR 878.4810
Intended UseIntended for use in dermatologic and general surgical proceduresIntended for use in dermatologic and general surgical procedures
Indications for UseExactly the same as K093547See K093547
Wavelength1064nm1064nm
Aiming beam630-680 nm (