(186 days)
No
The device description and intended use focus on the laser technology and its components. There is no mention of AI, ML, image processing, or any data-driven algorithms. The performance studies and training/test set descriptions are also not found, which would typically be present for an AI/ML device.
Yes
The device is described as an Nd:YAG laser system intended for surgical procedures, including ablation, vaporization, incision, and coagulation of soft tissue, which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
The device is intended for surgical procedures involving ablation, vaporization, incision, and coagulation of soft tissue, which are therapeutic actions, not diagnostic ones.
No
The device description explicitly lists multiple hardware components, including a laser rod, flashlamp, aiming beam diode laser, fiber-optic connector port, footswitch, power cord, and various delivery devices and accessories. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "surgical procedures involving open, laparoscopic and endoscopic ablation, vaporization, incision, and coagulation of soft tissue." This describes a therapeutic or surgical intervention performed directly on the patient's body.
- Device Description: The device description details a laser system and delivery accessories used for surgical procedures. It does not mention any components or processes related to testing samples of human origin (like blood, urine, tissue, etc.) outside of the body.
- Lack of IVD Keywords: There are no mentions of terms commonly associated with IVDs, such as "in vitro," "diagnostic," "assay," "test," "sample," "analyte," etc.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical laser used for treatment, not for analyzing samples.
N/A
Intended Use / Indications for Use
The PathoLase Family of PinPointe™ and PinPointe™ FootLaser™ Nd:YAG Lasers and the delivery accessories that are used with them are intended for use in surgical procedures involving open, laparoscopic and endoscopic ablation, vaporization, incision, and coagulation of soft tissue in the medical specialties of general and cosmetic dentistry, otolaryngology/ENT surgery, and dermatology & plastic surgery including:
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
- Hemostatis
- 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
Endonasal surgery (ablation, vaporization, incision, and coagulation of soft tissue) including:
- Lesions or tumors of the oral, nasal, glossal, pharyngeal & laryngeal tissues
- Tonsillectomy
- Adenoidectomy
Podiatry
Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
- Matrixectomy
- Periungual and subungual warts
- Plantar warts
- Radical nail excision
- Neuromas
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
Product codes
GEX
Device Description
The PathoLase Family of PinPointe™ and PinPointe™ FootLaser™ Nd:YAG Lasers are comprised of the following main components:
- Main console containing the major electrical components, including:
- A 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;
- A Delivery device fiber-optic connector port;
- A Control/ Display Panel with the:
- 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);
- Footswitch: 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;
- With Standoff: Reusable, cleanable, tip is provided for Guide Tip 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 (Previously Cleared in K011423):
- A 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:
- A 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 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:
- A Optical Fiber Striper;
- A 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
Oropharyngeal / Dental, General surgery sites, Endonasal, Podiatry (Matrixectomy, Periungual and subungual warts, Plantar warts, Radical nail excision, Neuromas), Dermatology and Plastic Surgery (Skin and subcutaneous tissue, Telangiectasia, Port wine lesions, Spider veins, Hemangiomas)
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)
Reference Device(s)
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
KO83616
JUN 1 2 2009
Section 5 - 510(k) Summary
I. General Information
Submitter:
PathoLase, Inc. 275 Airpark Boulevard Suite 500 Chico, CA 95973 Tel: 230-809-3800
Contact Person:
John Strisower Chairman & Chief Executive, PathoLase, Inc.
Summary Preparation Date: May 6, 2009
II. Names
Device Names:
PathoLase Family of PinPointe™ and PinPointe™ FootLaser™ Nd: Y AG Lasers (and delivery device accessories)
Primary Classification Names: . Laser Powered Surgical Instruments (and Accessories)
III. Predicate Devices
- Modified Lumenis VersaPulse PowerSuite Holmium (Ho:YAG) and Dual . Wavelength (Ho:YAG) Nd:YAG) Surgical Lasers and Delivery Devices with Accessories - 2100 nm & 1064 nm (K011703)
- Incisive InPulse Dental Laser 1064 nm (K011423). �
IV. Product Description
The PathoLase Family of PinPointe™ and PinPointe™ FootLaser™ Nd:YAG Lasers are comprised of the following main components:
- . Main console containing the major electrical components, including:
- A 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;
- A Delivery device fiber-optic connector port;
- A Remote interlock connector (External door interlock connector);
- A Control/ Display Panel with the:
1
KOS 3616
- A Connector ports for the footswitch and power cord;
- A Accessory holder (attached to the rear of the main console);
- . Footswitch:
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;
- With Standoff: Reusable, cleanable, tip is provided for Guide Tip 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 (Previously Cleared in K011423):
- A 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:
- A 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 The handpiece tips attach to the end of the location. handpiece. The optical fiber is threaded through both the handpiece and the handpiece tip;
- A Optical Fibers -Reusable, cleanable, sterilizable optical fibers (range of 200 - 1000 um diameter) provided non-sterile, clean and ready for sterilization (steam autoclave).
- Accessories: ●
A
- A Safety Glasses
- Tools: .
- A Optical Fiber Striper;
- A Optical Fiber Cleaver (carbide wedge, ceramic, or equivalent scribe for cleaving the optical fibers).
V. Rationale for Substantial Equivalence
The PathoLase Family of PinPointe™ and PinPointe™ FootLaser™ Nd:YAG Lasers share the same or similar indications for use, device operation, overall technical and functional capabilities, and therefore is substantially equivalent to the predicate devices.
VI. Safety and Effectiveness Information
The review of the indications for use and technical characteristics provided demonstrates that the PathoLase Family of PinPointe™ and PinPointe™ FootLaser™ Nd:YAG Lasers are substantially equivalent to the predicate devices.
2
083616
VII. Conclusion
The PathoLase Family of PinPointe™ and PinPointe™ FootLaser™ Nd:YAG Lasers were found to be substantially equivalent to the predicate devices.
The PathoLase Family of PinPointe™ and PinPointe™ FootLaser™ Nd:YAG Lasers share identical indications for use, similar design features, and functional features with, and thus are substantially equivalent to, the predicate devices.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
PathoLase, Incorporated A L Voss Associates % Ms. Anne Worden 3637 Bernal Avenue Pleasanton, California 94566
JUN 1 2 2003
Re: K083616
Trade/Device Name: PathoLase Family of PinPointe™ and PinPointe™
FootLaser™ Nd:YAG Lasers
Regulation Number: 21 CFR 878.4810
Regulation Name: Lascr Surgical Instrument for Use In General And Plastic Surgery and In Dermatology
Regulatory Class: II Product Code: GEX Dated: May 6, 2009 Received: May 8, 2009
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.
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 comply with all the Act's requirements, including, but not limited to: registration
4
Page 2-Ms. Worden
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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours
for
Mark N. Melkerson
Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known): K083616
Device Name: PathoLase Family of PinPointe™ and PinPointe™ FootLaser™ Nd: YAG Lasers
Indications for Use:
The PathoLase Family of PinPointe™ and PinPointe™ FootLaser™ Nd:YAG Lasers and the delivery accessories that are used with them are intended for use in surgical procedures involving open, laparoscopic and endoscopic ablation, vaporization, incision, and coagulation of soft tissue in the medical specialties of general and cosmetic dentistry, otolaryngology/ENT surgery, and dermatology & plastic surgery including:
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
- Hemostatis
- Implant recovery
- Lesion (tumor) removal
- Leukoplakia
- Operculectomy
- Oral papillectomy
- Pulpotomy
Prescription Use (Part 21 CFR 801 Subpart D) ** Page 1 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)
Nulke Odes Formen
(Division S (Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number
Page 1 of 4
Premarket Notification, 510(k) Submission for: PathoLase Family of PinPointe™ and PinPointe™ FootLaser™ Nd: YAG Lasers Section 4: Indications for Use
6
510(k) Number (if known): K083616
Device Name: PathoLase Family of PinPointe™ and PinPointe™ FootLaser™ Nd: YAG Lasers
Indications for Use - Continued:
Oropharangeal / Dental Surgery - Continued
- . 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
Prescription Use V
AND/OR (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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil K. Oslen Forman
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K083616
Page 2 of 4
Premarket Notification, 510(k) Submission for: PathoLase Family of PinPointe™ and PinPointe™ FootLaser™ Nd: YAG Lasers
Section 4: Indications for Use
7
510{k) Number (if known): K083616
Device Name: PathoLase Family of PinPointe™ and PinPointe™ FootLaser™ Nd:YAG Lasers
Indications for Use - Continued:
General Surgery - Continued
- 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 . ●
Podiatry
Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
- . Matrixectomy
- Periungual and subungual warts .
- Plantar warts
- Radical nail excision
- Neuromas
** Page 3 of 4 **
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)
Nul R.P. O'sada Firman
(Division Sign-C Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K083616
Page 3 of 4
Premarket Notification, 510(k) Submission for: PathoLase Family of PinPointe™ and PinPointe™ FootLaser™ Nd: YAG Lasers Section 4: Indications for Use
8
510(k) Number (if known): _ K083616
Device Name: PathoLase Family of PinPointe™ and PinPointe™ FootLaser™ Nd:YAG Lasers
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 �
- Telangiectasia
- Port wine lesions
- Spider veins
- Hemangiomas
- Plantar warts
- Periungual and subungual warts
- Removal of tattoos
- Debridement of decubitus ulcer
- Treatment of keloids
*** Page 4 of 4 ***
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)
Net Rf Ogden for mktm
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number
Page 4 of 4
Premarket Notification, 510(k) Submission for: PathoLase Family of PinPointe™ and PinPointe™ FootLaser™ Nd: YAG Lasers Section 4: Indications for Use