(332 days)
Not Found
No
The summary describes a laser system for soft tissue procedures and onychomycosis treatment. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
Explanation: The device is indicated for various surgical procedures, including ablation, vaporization, excision, incision, and coagulation of soft tissue, and for the temporary increase of clear nail in patients with onychomycosis, all of which are considered therapeutic applications.
No
Explanation: The device is intended for surgical procedures involving ablation, vaporization, excision, incision, and coagulation of soft tissue, and for the temporary increase of clear nail in patients with onychomycosis, which are therapeutic and treatment-oriented functions, not diagnostic ones.
No
The device description clearly outlines numerous hardware components including a main console, laser rod, aiming beam diode laser, delivery devices (fibers, handpieces, tips), footswitch, and accessories. This is a hardware-based laser system, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The PinPointe™ FootLaser™ is a laser system used for surgical procedures involving the ablation, vaporization, excision, incision, and coagulation of soft tissue. It directly interacts with the patient's body during treatment.
- Intended Use: The intended uses listed are all surgical procedures performed on the patient, not diagnostic tests performed on specimens from the patient. Even the indication for onychomycosis is for temporary increase of clear nail, which is a treatment outcome, not a diagnostic result from a specimen.
Therefore, the PinPointe™ FootLaser™ is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PinPointe™ FootLaser™ and the delivery accessories that are used with them are intended for use in surgical procedures involving open, laparoscopic and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue in the medical specialties of general and cosmetic dentistry, otolaryngology/ENT surgery, and dermatology & plastic surgery including intraoral soft tissue dental surgery, oral maxillo-facial and cosmetic surgery, general surgery, E.N.T. surgery, podiatry, and dermatology and plastic surgery.
Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
- Matrixectomy
- Periungual and subungual warts
- Plantar warts
- Radical nail excision
- Neuromas
The PinPointe™ FootLaser™ is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).
Dermatology and plastic surgery (ablation, vaporization, excision, and coagulation of soft tissue) including:
- Lesions of skin and subcutaneous tissue
- Telangjectasia
- Port wine lesions
- Spider veins
- Hemangiomas
- Plantar warts
- Periungual and subungual warts
- Removal of tattoos
- Debridement of decubitus ulcer
- Treatment of keloids
Oropharangeal / Dental Surgery Indicated for:
- Abscess incision and drainage
- Aphthous ulcers treatment
- Biopsies, excisional and incisional
- Crown lengthening
- Exposure of unerupted / partially erupted teeth
- Fibroma removal
- Frenectomy
- Frenotomy
- Gingival incision and excision
- Gingivectomy
- Gingivoplasty
- Hemostasis
- Implant recovery
- Lesion (tumor) removal
- Leukoplakia
- Operculectomy
- Oral papillectomy
- Pulpotomy
- Pulpotomy as adjunct to root canal therapy
- Removal of filling material such as gutta percha or resin as adjunct treatment during root canal re-treatment
- Selective ablation of enamel (first degree) caries removal
- Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket) to improve clinical indices including gingival index, gingival bleeding index. probe depth, attachment loss, and tooth mobility
- Tissue retraction for impressions
- Vestibuloplasty
General Surgery Indicated for:
- Open, laparoscopic, and endoscopic general surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
- Cholecystectomy
- Lymphadenectomy
- Mastectomy
- Partial nephrectomy
- Hepatectomy
- Pilonidal cystectomy
- Pancreatectomy
- Resection of lipoma
- Splenectomy
- Pelvic adhesiolysis
- Hemorrhoidectomy
- Removal of lesions
- Thyroidectomy
- Removal of polyps
- Parathyroidectomy
- Removal of tumors
- Herniorrhaphy
- Tumor biopsy
- Tonsillectomy
- Debridement of decubitus ulcers
- Appendectomy
Endonasal Surgery (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 PinPointe™ FootLaser™ is comprised of the following main components:
- Main console containing the major electrical components, including:
- Control/ Display Panel with the:
- Keyswitch (that controls authorized access to the laser system);
- emergency Laser Stop button;
- Displays (laser emission indicator, average power, pulse energy, repetition rate)
- Standby button (default mode when laser system turned on - places system into the Standby mode preventing laser emission).
- Ready button (places system into the Ready mode allowing laser emission when the footswitch is depressed and a fiber optic is properly attached);
- A 1064 nm treatment laser (solid state Nd: YAG laser rod) with flashlamp and associated light regulation components and electronics;
- A 630 -680 nm (red) aiming beam diode laser;
- Delivery device fiber-optic connector port;
- Remote interlock connector (External door interlock connector);
- Connector ports for the footswitch and power cord;
- Accessory holder (attached to the rear of the main console);
- Control/ Display Panel with the:
- Footswitch:
- Medical grade power cord:
- Delivery Devices for Non-Contact and Contact with Intact Skin/Tissue:
- Guide Tip -No Standoff: Reusable, cleanable, tip is provided for noncontact use to direct and control the placement of the laser beam (free beam) at the treatment location. The Guide tip attaches to the end of the handpiece. The optical fiber is threaded through the handpiece and fits securely into the bore of the Guide tip;
- Guide Tip -With Standoff: Reusable, cleanable, tip is provided for minimal-contact with intact skin/ tissue to direct and control the placement of the laser beam at the treatment location. The Guide tip attaches to the end of the handpiece. The optical fiber is threaded through the handpiece and fits securely into the bore of the Guide tip;
- Delivery Devices for Contact with Breached Surfaces:
- Reusable, cleanable, sterilizable optical fibers (range of Optical Fibers -200 - 1000 um diameter) provided non-sterile, clean and ready for sterilization (steam autoclave).
- Reusable, cleanable, sterilizable handpieces (large and Handpieces small diameter shafts) provided non-sterile, clean and ready for sterilization (steam autoclave). The optical fiber is threaded through the handpiece and secured and held in place with the handpiece locking cap;
- Handpiece Tips. Disposable single-use tips are provided in straight and 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)
Clinical study demonstrated the safety and effectiveness of the PinPointe™ FootLaser™ for use for the temporary increase of clear nail at 6 and 12 months following treatment in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).
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.
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
K093)'45
CONFIDENTIAL
lncisive
Section 5 - 510(k) Summary
I. General Information
OCT 1 5 2010
Submitter:
Incisive, Inc. 3095 Richmond Parkway, Suite 213 Richmond, CA 94806 Tel: 510-669-9401
Contact Person:
Summary Preparation Date:
Chief Executive Officer, Incisive, Inc October 13, 2010
Michael Yessik, PhD
giee
Inc.
II. Names
Trade Name(s):
PinPointe™ FootLaser™ (and delivery device accessories)
Common Name(s):
Laser Powered Surgical Instruments
Primary Classification Names:
Laser Powered Surgical Instruments (and Accessories) (21 CFR Part 878.4810, Product Code GEX)
III. Predicate Devices
- . Incisive Family of InPulse Nd: Y AG Lasers (K083215);
- PathoLase Family of PinPointe™ and PinPointe™ FootLaser™ Nd:YAG Lasers . (K083616).
IV. Product Description
.
The PinPointe™ FootLaser™ is comprised of the following main components:
- Main console containing the major electrical components, including:
- Control/ Display Panel with the: A
- . Keyswitch (that controls authorized access to the laser system);
- . emergency Laser Stop button;
- . Displays (laser emission indicator, average power, pulse energy, repetition rate)
- . Standby button (default mode when laser system turned on - places system into the Standby mode preventing laser emission).
- Ready button (places system into the Ready mode allowing laser . emission when the footswitch is depressed and a fiber optic is properly attached);
- A 1064 nm treatment laser (solid state Nd: YAG laser rod) with flashlamp and associated light regulation components and electronics;
- A 630 -680 nm (red) aiming beam diode laser;
- Delivery device fiber-optic connector port; A
- Remote interlock connector (External door interlock connector); A
- Connector ports for the footswitch and power cord; A
- Accessory holder (attached to the rear of the main console); A
- Control/ Display Panel with the: A
1
CONFIDENTIAL
- . Footswitch:
A
A
A
- Medical grade power cord: .
- Delivery Devices for Non-Contact and Contact with Intact Skin/Tissue:
Guide Tip -No Standoff: Reusable, cleanable, tip is provided for noncontact use to direct and control the placement of the laser beam (free beam) at the treatment location. The Guide tip attaches to the end of the handpiece. The optical fiber is threaded through the handpiece and fits securely into the bore of the Guide tip;
- Guide Tip -With Standoff: Reusable, cleanable, tip is provided for minimal-contact with intact skin/ tissue to direct and control the placement of the laser beam at the treatment The Guide tip attaches to the end of the location. The optical fiber is threaded through the handpiece. handpiece and fits securely into the bore of the Guide tip;
- Delivery Devices for Contact with Breached Surfaces:
109354
- A Reusable, cleanable, sterilizable optical fibers (range of Optical Fibers -200 - 1000 um diameter) provided non-sterile, clean and ready for sterilization (steam autoclave).
- Reusable, cleanable, sterilizable handpieces (large and Handpieces small diameter shafts) provided non-sterile, clean and ready for sterilization (steam autoclave). The optical fiber is threaded through the handpiece and secured and held in place with the handpiece locking cap;
- Handpiece Tips . Disposable single-use tips are provided in straight and A curved configurations and are used to direct and control the placement of the optical fiber tip at the treatment The handpiece tips attach to the end of the location. handpiece. The optical fiber is threaded through both the handpiece and the handpiece tip:
- Accessories: ●
-
Safety Glasses
-
- Tools: ●
- Optical Fiber Striper; A
- A Optical Fiber Cleaver (carbide wedge, ceramic, or equivalent scribe for cleaving the optical fibers).
V. Indications for Use
The PinPointe™ FootLaser™ and the delivery accessories that are used with them are intended for use in surgical procedures involving open, laparoscopic and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue in the medical specialties of general and cosmetic dentistry, otolaryngology/ENT surgery, and dermatology & plastic surgery including intraoral soft tissue dental surgery, oral maxillofacial and cosmetic surgery, general surgery, E.N.T. surgery, podiatry, and dermatology and plastic surgery.
2
Podiatry
Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
. .
- . Matrixectomy
- . Radical nail excision
- Periungual and subungual warts .
1693541
- Plantar warts .
- Neuromas ●
The PinPointe™ FootLaser™ is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).
.
.
.
.
.
Dermatology and Plastic Surgery
Dermatology and plastic surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
- . Lesions of skin and subcutaneous tissue
- . Telangiectasia
- Port wine lesions
- Spider veins �
- Hemangiomas 0
Oropharangeal / Dental Surgery
Indicated for:
.
- Abscess incision and drainage .
- Aphthous ulcers treatment .
- . Biopsies, excisional and incisional
- Crown lengthening .
- . Exposure of unerupted / partially erupted teeth
- . Fibroma removal
- Frenectomy .
- . Frenotomy
- Gingival incision and excision .
- . Gingivectomy
- Gingivoplasty ●
- Hemostasis .
- . Implant recovery
- Lesion (tumor) removal .
- Leukoplakia .
- Operculectomy ●
- Oral papillectomy .
General Surgery
Indicated for:
-
Open, laparoscopic, and endoscopic general surgery (ablation, vaporization, . incision, excision, and coagulation of soft tissue) including:
-
Cholecystectomy -
-
-Lymphadenectomy
-
-Mastectomy
-
Partial nephrectomy .
-
Hepatectomy
-
Thyroidectomy -
Removal of lesions -
-Removal of polyps
-
Parathyroidectomy -
-
Removal of tumors -
-
Pulpotomy ●
Plantar warts
Removal of tattoos
Treatment of keloids
- . Pulpotomy as adjunct to root canal therapy
Periungual and subungual warts
Debridement of decubitus ulcer
-
Removal of filling material such as . gutta percha or resin as adjunct treatment during root canal retreatment
-
. Selective ablation of enamel (first degree) caries removal
-
Sulcular debridement (removal of . diseased or inflamed soft tissue in the periodontal pocket) to improve clinical indices including gingival index, gingival bleeding index. probe depth, attachment loss, and tooth mobility
-
Tissue retraction for impressions .
-
. Vestibuloplasty
3
CONFIDENTIAL
- Pilonidal cystectomy
- Pancreatectomy -
- Resection of lipoma -
- Splenectomy "
- Pelvic adhesiolysis -
- Hemorrhoidectomy -
- Herniorrhaphy
- Tumor biopsy .
- Tonsillectomy
- Debridement of decubitus ulcers
- Appendectomy
Endonasal Surgery
Endonasal surgery (ablation, vaporization, incision, and coagulation of soft tissue) including:
- Lesions or tumors of the oral, nasal, glossal, pharyngeal & laryngeal tissues .
- Tonsillectomy .
- . Adenoidectomy
The safety and effectiveness of the PinPointe™ FootLaser™ for use for the temporary increase of clear nail in patients with onychomycosis was demonstrated in clinical studies.
VI. Summary of Technological Characteristics
The technological characteristics of the PinPointe™ FootLaser™ are identical to those of the predicate devices.
| Characteristic | K093547 - PinPointe™
FootLaser™ and Delivery
Devices; PinPointe USA, Inc. | | | K083616 - PathoLase Family of
PinPointe™ and PinPointe™
FootLaser™ Lasers; PathoLase,
Inc. | | | K0832153 - Incisive Family of
InPulse Nd:YAG Lasers;
Incisive, LLC | | |
|------------------------------------|---------------------------------------------------------------------------------|------------|------------|-----------------------------------------------------------------------------------------------------|---------|-----------|--------------------------------------------------------------------------|------------|------------|
| Wavelength | 1064 nm | | | 1064 nm | | | 1064 nm | | |
| Aiming Beam | 630-680 nm (≤ 2.5 mW) | | | 630-680 nm (≤ 2.5 mW) | | | 630-680 nm (≤ 2.5 mW) | | |
| Model | 6 W | 30 W | 100 W | 6 W | 30 W | 100 W | 6 W | 30 W | 100 W |
| Energy Per Pulse
(mJ) | 20-200 | 20-1000 | 20 - 3500 | 20-200 | 20-1000 | 20 - 3500 | 20-200 | 20-1000 | 20 - 3500 |
| Power (Watts) | ≤ 6 | ≤ 30 | ≤ 100 | ≤ 6 | ≤ 30 | ≤ 100 | ≤ 6 | ≤ 30 | ≤ 100 |
| Pulse Duration
(μsec) | 100 - 700 | 350 - 3000 | 350 - 3000 | 100 - 3000 | | | 100 - 700 | 350 - 3000 | 350 - 3000 |
| Output Mode | Pulsed, Multi-Mode | | | Pulsed, Multi-Mode | | | Pulsed, Multi-Mode | | |
| Repetition Rate | 5 - 100 Hz | | | 5 - 100 Hz | | | 5-100 Hz | | |
| Laser Media | Flashlamp-Pumped Solid State
Laser Rod | | | Flashlamp-Pumped Solid State
Laser Rod | | | Flashlamp-Pumped Solid State
Laser Rod | | |
| User Interface | Push-button control panel | | | LCD Color touch screen | | | Push-button control panel | | |
| Laser Activation | Footswitch | | | Footswitch | | | Footswitch | | |
| Delivery Devices
• How supplied | • Non-sterile, reusable,
cleanable, sterilizable | | | • Non-sterile, reusable, cleanable,
sterilizable | | | • Non-sterile, reusable, cleanable,
sterilizable | | |
| System
Dimensions | 32" x 13" x 14" (H x W x D) | | | 32" x 13" x 14" (H x W x D) | | | 32" x 13" x 14" (H x W x D) | | |
| System Weight | 17.2 kg (38 lbs) | | | 17.2 kg (38 lbs) | | | 17.2 kg (38 lbs) | | |
| Electrical Reqs. | 90-130 VAC, 50/60 Hz
200-240 VAC, 50/60 Hz | | | 90-130 VAC, 50/60 Hz
200-240 VAC, 50/60 Hz | | | 90-130 VAC, 50/60 Hz
200-240 VAC, 50/60 Hz | | |
S002-024-1 K093547
4
093)'45'
Clinical study demonstrated the safety and effectiveness of the PinPointe™ FootLaser™ for use for the temporary increase of clear nail at 6 and 12 months following treatment in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).
VIII. Safety and Effectiveness Information
The review of the indications for use, technical characteristics, and clinical study results provided demonstrates that the PinPointe™ FootLaser™ is substantially equivalent to the predicate devices and is safe and effective for use for the temporary increase of clear nail at 6 and 12 months following treatment in patients with onychomycosis.
IX. Conclusion
The PinPointe™ FootLaser™ was found to be substantially equivalent to the predicate devices.
The PinPointe™ FootLaser™ share identical indications for use, similar design features, and functional features with, and thus are substantially equivalent to, the predicate devices.
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or body. The symbol is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Incisive, Inc. % Ms. Anne Worden Regulatory Consultant 3637 Bernal Avenue Pleasanton, California 94566
OCT 15 2010
Re: K093545
Trade/Device Name: PinPointe FootLaser and Accessories Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: October 13, 2010 Received: October 14, 2010
Dear Ms. Worden:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must
6
Page 2 - Ms. Anne Worden
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of martistal) device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (2) CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 100-1000.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 1 1 8809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification". 21 CFR Preu 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free nomber (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use Statement
510(k) Number (if known): K093545
Device Name: PinPointe™ FootLaser™
Indications for Use:
The PinPointe™ FootLaser™ and the delivery accessories that are used with them are intended for use in surgical procedures involving open, laparoscopic and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue in the medical specialties of general and cosmetic dentistry, otolaryngology/ENT surgery, and dermatology & plastic surgery including intraoral soft tissue dental surgery, oral maxillo-facial and cosmetic surgery, general surgery, E.N.T. surgery, podiatry, and dermatology and plastic surgery.
Podiatry
Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
- Matrixectomy .
- Periungual and subungual warts .
- Plantar warts .
- Radical nail excision .
- Neuromas t
The PinPointe™ FootLaser™ is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).
*** Page 1 of 4 ***
V Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Huening
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093545
Premarket Notification, 510(k) Submission for: Incisive PinPointe™ FootLaserTM
Section 4: Indications for Use
8
Indications for Use Statement - Continued
| 510(k) Number (if known): | K093545 |
|---|---|
| Device Name: | PinPointe™ FootLaser™ |
13 200
Indications for Use - Continued.### Dermatology and Plastic Surgery
Dermatology and plastic surgery (ablation, vaporization, excision, and coagulation of soft tissue) including:
- Lesions of skin and subcutaneous tissue .
- � Telangjectasia
- Port wine lesions .
- . Spider veins
- Hemangiomas .
- . Plantar warts
- Periungual and subungual warts
- . Removal of tattoos
- . Debridement of decubitus ulcer
- Treatment of keloids .
Oropharangeal / Dental Surgery
Indicated for:
- Abscess incision and drainage .
- . Aphthous ulcers treatment
- Biopsies, excisional and incisional .
- . Crown lengthening
- . Exposure of unerupted / partially erupted teeth
- . Fibroma removal
- Frenectomy .
- . Frenotomy
- Gingival incision and excision t
- Gingivectomy .
- Gingivoplasty �
Prescription Use > (Part 21 CFR 801 Subpart D) *** Page 2 of 4 *** AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
OCT 1 5 - 2010
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED).
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nil R+Daler for mxm
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
510(k) Number K093545
Page 2 of 4
Premarket Notification, 510(k) Submission for: Incisive PinPointe™ FootLaserTM
Section 4: Indications for Use
9
Indications for Use Statement - Continued
510(k) Number (if known): K093545
Device Name: PinPointeTM FootLaser™
Indications for Use - Continued:
Oropharangeal / Dental Surgery - Continued
Indicated for:
- . Hemostasis
- Implant recovery .
- Lesion (tumor) removal .
- . Leukoplakia
- Operculectomy .
- . Oral papillectomy
- Pulpotomy .
- . Pulpotomy as adjunct to root canal therapy
- Removal of filling material such as gutta percha or resin as adjunct treatment during root ● canal re-treatment
- Selective ablation of enamel (first degree) caries removal .
- Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal . pocket) to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss, and tooth mobility
- Tissue retraction for impressions .
- Vestibuloplasty
General Surgery
Indicated for:
- Open, laparoscopic, and endoscopic general surgery (ablation, vaporization, incision, . excision, and coagulation of soft tissue) including:
- Cholecystectomy -
- Lymphadenectomy -
- -Mastectomy
- Partial nephrectomy -
- Hepatectomy
V Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
*** Page 3 of 4 **
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093545
Page 3 of 4
Premarket Notification, 510(k) Submission for: Incisive PinPointe™ FootLaserTM
Section 4: Indications for Use
10
Indications for Use Statement - Continued
510(k) Number (if known): K093545
Device Name: PinPointe™ FootLaser™
Indications for Use - Continued:
General Surgery - Continued
Indicated for:
- Pilonidal cystectomy -
- Pancreatectomy -
- Resection of lipoma -
- Splenectomy -
- Pelvic adhesiolysis -
- Hemorrhoidectomy -
- Removal of lesions -
- Thyroidectomy -
- Removal of polyps -
- Parathyroidectomy -
- Removal of tumors ﺖ
- Herniorrhaphy -
- Tumor biopsy -
- Tonsillectomy -
- Debridement of decubitus ulcers
- Appendectomy
Endonasal Surgery
Endonasal surgery (ablation, vaporization, incision, and coagulation of soft tissue) including:
- Lesions or tumors of the oral, nasal, glossal, pharyngeal & laryngeal tissues .
- . Tonsillectomy
- Adenoidectomy .
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Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neutee Dryden forman
(Division Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093545
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Premarket Notification, 510(k) Submission for: Incisive PinPointe™ FootLaserTM
Section 4: Indications for Use