(30 days)
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 intended use.
Yes
The device is described as being used for surgical procedures and for the temporary increase of clear nail in patients with onychomycosis, both of which are therapeutic interventions.
No
The device description and intended use clearly state that the PinPointe™ FootLaser™ is used for surgical procedures involving ablation, vaporization, excision, incision, and coagulation of soft tissue, as well as for the temporary increase of clear nail in patients with onychomycosis. These are therapeutic actions, 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 not a software-only device.
Based on the provided information, the PinPointe™ FootLaser™ is not an In Vitro Diagnostic (IVD) device.
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 for diagnosis, monitoring, or screening. This testing is performed outside of the living body (in vitro).
- PinPointe™ FootLaser™ Function: The description clearly states that the PinPointe™ FootLaser™ is a laser system used for surgical procedures involving the direct application of laser energy to soft tissue within the body (in vivo). It performs actions like ablation, vaporization, excision, incision, and coagulation.
- Intended Use: The intended uses listed are all surgical procedures performed directly on the patient's body for treatment purposes, not for analyzing specimens.
Therefore, the PinPointe™ FootLaser™ is a surgical laser device, not an IVD.
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 ablation, 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 (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
- 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
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)
- LCD screen user interface permitting selection of treatment ● emission when the footswitch is depressed and a fiber optic is properly attached);
- Control/ Display Panel with the:
- 1064 nm treatment laser (solid state Nd:Y AG 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 non-contactuse to direct and . control the placement of the laser beam (free 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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, foot, nails, skin, subcutaneous tissue, oral, nasal, glossal, pharyngeal, laryngeal, specific organs (gallbladder, lymph nodes, breast, kidney, liver, spleen, thyroid, parathyroid, appendix), connective tissue (hemorrhoids, hernias).
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)
Not Found
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 PinPointe FootLaser and Accessories
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
MAR 2 1 2013
Section 8 – Special 510(k) Summary
I. General Information
Submitter:
Nuvolase, Inc.
Contact Person:
Steve Duddy
530-809-1970 ext. 207
Summary Preparation Date:
February 11, 2013
II. Names
Device Name(s): PinPointe FootLaser
Primary Classification Name(s): Electrosurgical cutting and coagulation device and accessories
III. Predicate Devices
- K093547 PinPointe FootLaser and Accessories .
1
IV. Product Description
The PinPointe™ FootLaser™ is comprised of the following main components:
- Main console containing the major electrical components, including: t
- 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:Y AG 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 (free 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 PinPointe™ FootLaser™ and the delivery accessories that are used with them are intended for use in surgical procedures involving open, laparoscopic ablation, 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 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, 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 l
- . 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 PinPointe Footlaser are substantially equivalent to those of the predicate device.
| K093547 | ||
|---|---|---|
| Characteristic | PinPointe FootLaser | 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 ( |