(332 days)
Not Found
No
The summary describes a laser system for soft tissue ablation and coagulation. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is clearly indicated for various surgical procedures, including ablation, vaporization, excision, incision, and coagulation of soft tissue, as well as for the temporary increase of clear nail in patients with onychomycosis, all of which are medical treatments.
No
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "surgical procedures involving open, laparoscopic and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue." This description refers to therapeutic interventions rather than diagnostic processes. There is no mention of the device being used to identify or determine the nature of a disease or condition. The "Device Description" also details components related to laser emission and delivery for treatment, not diagnosis.
No
The device description clearly outlines numerous hardware components, including a main console, laser components, delivery devices (fibers, handpieces, tips), and accessories like safety glasses and tools. This is not a software-only device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly indicate that the PinPointe™ FootLaser™ is a surgical laser used for direct treatment of soft tissue on the patient's body. It performs procedures like ablation, vaporization, excision, and coagulation.
- The device description does not mention any components or processes related to analyzing biological samples. There is no mention of reagents, test strips, analyzers, or any other elements typically associated with IVD devices.
- The performance study described focuses on the clinical outcome of treating onychomycosis directly on the patient's nail. It does not involve the analysis of a biological specimen to diagnose or monitor a condition.
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 maxillofacial 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, 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 / 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 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
- Hemiorrhaphy
- Tumor biopsy
- Tonsillectomy
- Debridement of decubitus ulcers
- Appendectomy
Endonasal Surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
- Lesions or tumors of the oral, nasal, glossal, pharyngeal & laryngeal tissues
- Tonsillectomy
- Adenoidectomy
Product codes
PDZ, 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:
- Kevswitch (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);
- 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:
- No Standoff: Reusable, cleanable, tip is provided for non-Guide Tip contact 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:
- 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 (clear nail in patients with onychomycosis), skin and subcutaneous tissue, oropharyngeal/dental tissues (intraoral soft tissue), nasal, glossal, pharyngeal & laryngeal tissues.
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
693547
CONFIDENTIAL
Section 5 - 510(k) Summary
DCT1 5 2010
I. General Information
Submitter:
PinPointe USA. Inc. 275 Airpark Boulevard Suite 100 Chico, CA 95973 530-809-3800 Tel: Fax: 866-235-1386
USA. Inc.
John Strisower Chief Executive Officer, PinPointe USA, Inc
Summary Preparation Date:
October 13, 2010
II. Names
Trade Name(s):
Contact Person:
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
- PathoLase Family of PinPointe™ and PinPointe™ FootLaser™ Nd:YAG Lasers ● (K083616)
- Incisive Family of InPulse Nd: Y AG Lasers (K083215). .
Product Description IV.
:
.
The PinPointe™ FootLaser™ is comprised of the following main components:
- Main console containing the major electrical components, including:
-
Control/ Display Panel with the:
- Kevswitch (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 ● cmission 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;
- A 630 -680 nm (red) aiming beam diode laser;
- Delivery device fiber-optic connector port; A
- Remote interlock connector (External door interlock connector); A
-
1
- Connector ports for the footswitch and power cord; A
- Accessory holder (attached to the rear of the main console); A
- . Footswitch;
A
- Medical grade power cord; .
- Delivery Devices for Non-Contact and Contact with Intact Skin/Tissue: .
- No Standoff: Reusable, cleanable, tip is provided for non-Guide Tip contact 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: ●
- Reusable, cleanable, sterilizable optical fibers (range of A Optical Fibers . 200 - 1000 um diameter) provided non-sterile, clean and ready for sterilization (steam autoclave).
- Handpieces -Reusable, cleanable, sterilizable handpieces (large and A 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:
- A Safety Glasses
- . Tools:
- Optical Fiber Striper; A
- Optical Fiber Cleaver (carbide wedge, ceramic, or equivalent scribe for cleaving A 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
-
Plantar warts .
-
. Neuromas
Plantar warts
Removal of tattoos
Treatment of keloids
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.).
D
.
.
.
.
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 ●
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:
.
- Pulpotomy ● 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 �
-
Open, laparoscopic, and endoscopic general surgery (ablation, vaporization, . incision, excision, and coagulation of soft tissue) including:
1
.
-
Cholecystectomy .
-
Lymphadenectomy -
-
Mastectomy -
- Partial nephrectomy
-
Hepatectomy .
-
-Parathyroidectomy -Removal of tumors
Removal of lesions
Removal of polyps
Thyroidectomy
Premarket Notification, 510(k) Submission for: PinPointe™ FootLaser™
3
Kog3547
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 | K093545 - PinPointe™
FootLaser™ and Delivery
Devices; Incisive, 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 | | |
4
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 features a stylized eagle or bird-like figure with outstretched wings, positioned above the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is circular in shape.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 13, 2013
PinPointe USA. Inc. % Ms. Anne Worden Regulatory Consultant 3637 Bernal Avenue Pleasanton, California 94566
Re: K093547
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: PDZ, GEX Dated: October 13, 2010 Received: October 14, 2010
Dear Ms. Worden:
This letter corrects our substantially equivalent letter of October 15, 2010.
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. 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
6
Page 2 - Ms. Anne Worden
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 CFR Part 807); labeling (21 CFR Part 801; medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm.
Sincerely vours. FOR
Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use Statement
OCT 1 5 2010
| 510(k) Number (if known): | K093547 |
|---|---|
| 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 specialites 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 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 ***
Prescription Use V (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)
Neil R.P. Ogden for mxm
Division Size 500
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093547
Page 1 of 4
Premarket Notification, 510(k) Submission for: PinPointe™ FootLaser™
Section 4: Indications for Use
8
Indications for Use Statement - Continued
510(k) Number (if known): K093547
| Device Name: | PinPointe™ FootLaser™ |
|---|---|
| -------------- | ----------------------- |
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
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
Prescription Use
(Part 21 CFR 801 Subpart D)
*** Page 2 of 4 ***
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number: K093547
Page 2 of 4
Premarket Notification, 510(k) Submission for: PinPointe™ FootLaserTM
Section 4: Indications for Use
9
Indications for Use Statement - Continued
510(k) Number (if known): K093547
Device Name: PinPointe™ 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 cnamel (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 .
Prescription Use > (Part 21 CFR 801 Subpart D) *** Page 3 of 4 *** 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)
$\frac{\text{Nid R.P.Q.den}}{\text{(Division Sigh-Off)}}$ for MXM
Division of Surgical, Orthopedic,
and Restorative Devices
510(k) Number K093547
Page 3 of 4
Premarket Notification, 510(k) Submission for: PinPointe™ FootLaser™
Section 4: Indications for Use
10
Indications for Use Statement - Continued
510(k) Number (if known): K093547
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 -
- Hemiorrhaphy .
- Tumor biopsy .
- Tonsillectomy .
- Debridement of decubitus ulcers .
- Appendectomy
Endonasal Surgery
Endonasal surgery (ablation, vaporization, incision, excision, 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)
Neil R.P. Ogden for mam
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
510(k) Number K093547
Page 4 of 4
Premarket Notification, 510(k) Submission for: PinPointe™ FootLaser™
Section 4: Indications for Use