(77 days)
CoolTouch Varia Nd:YAG laser system, Patholase PinPointe FootLaser Nd:YAG laser system, Lumenis VersaPulse PowerSuite Ho:YAG/ Nd:YAG laser system
No
The document describes a laser system for various surgical and dermatological applications. There is no mention of AI, ML, image processing, or any data-driven decision-making components in the device description or performance studies.
Yes.
The device is used for various medical procedures such as coagulation, incision, excision, ablation, and vaporization of soft tissues, as well as for treating specific conditions like vascular lesions, GI tract issues, and tumors across multiple surgical and dermatological specialties, all of which fall under therapeutic applications.
No
Explanation: The device is described as a laser system used for various surgical procedures involving the coagulation, incision, excision, ablation, and vaporization of soft tissues. These are therapeutic actions, not diagnostic ones.
No
The device description explicitly states it consists of a cabinet housing hardware components like a power supply, cooling system, microcontroller, laser, foot switch, and fiber optic delivery system. This indicates it is a hardware device, not software-only.
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 this laser system is used for direct treatment and manipulation of various tissues within the human body (coagulation, incision, ablation, etc.).
- There is no mention of analyzing biological samples. The device description focuses on the laser's physical properties and delivery system, not on any components or processes for analyzing blood, urine, tissue samples, or other bodily fluids.
- The applications are surgical and therapeutic. All the listed applications involve using the laser to perform procedures on living tissue for treatment purposes.
Therefore, this device falls under the category of a therapeutic medical device, specifically a surgical laser system, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The soft tissue applications are for the coagulation, photocoagulation, incision/excision, ablation, and vaporization of soft tissues including skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands.
Dermatology: For hair removal (destruction of hair follicles) in all skin types and for coagulation and hemostasis of vascular lesions and soft tissue applications. In addition to the tissue types cited, pigmented lesions to reduce lesion size; for patients with lesions that would potentially benefit from aggressive treatment; for patients with lesions that have not responded to other laser treatments. Also for the treatment of fine lines and wrinkles.
Endoscopic/Laparoscopic General Surgery: Incision/excision and cutting, ablation, coagulation/hemostasis of soft tissue in endoscopic, laparoscopic surgery applications, including but not limited to cholecystectomy, appendectomy, vagotomy, and pyloromyotomy.
Gastroenterology: Tissue ablation and hemostasis in the GI tract; esophageal neoplastic obstructions including squamous cell carcinoma and adenocarcinoma; GI hemostasis; including varices, esophagitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, angiodysplasia, stomal ulcers, nonbleeding ulcers, gastric erosions, GI tissue ablation, including benign and malignant neoplasms, angiodysplasia; polyps, ulcer, colitis, and hemorrhoids.
General Surgery: Soft tissue in general surgery applications, skin incisions, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors, lesions, tissue ablation, vessel coagulation.
Gynecology: Treatment of menorrhagia by photocoagulation of the endometrial lining of the uterus, ablation of endometrial implants and/or peritoneal adhesions, soft tissue excision procedures such as conization of the cervix, intrauterine gynecologic procedures where cutting, ablation and/or vessel coagulation may be indicated including submucous fibroids, benign endometrial polyps, uterine septum.
Head and Neck/Otorhinolaryngology (ENT): Coagulation, photocoagulation, incision/excision, ablation, and vaporization of soft tissue.
Hemostasis during surgery: Adjunctive coagulation and hemostasis (control of bleeding) during surgery (endoscopic, laparoscopic, and open procedures).
Neurosurgery: Hemostasis of pituitary tumor, meningioma, hemagioblastoma, AVMs, glioma, glioblastoma, astrocytoma, oligodendroglioma.
Oculoplastics: Incision, excision, vaporization, ablation, and coagulation of soft tissues in oculoplastic procedures such as operations on the lacrimal system, operation on the eyelids, removal of biopsy or orbital tumors, enucleation of the eyeball, exteneration of orbital contents.
Orthopedics: Incision, excision, cutting, ablation and/or hemostasis of intra-articular tissue in orthopedic surgical and arthroscopic applications.
Plastic Surgery: Incision, excision, cutting, coagulation, and vaporization of soft tissue.
Pulmonary/Thoracic Surgery: Palliative treatment of benign and malignant pulmonary airway obstructions including squamous cell carcinoma, adenocarcinoma, carcinoid, benign tumors, granulomas, and benign strictures.
Thoracic Surgery: Incision, excision, cutting, coagulation, and vaporization of soft tissue, including lung tissue, in thoracic applications including but not limited to isolation of vessels for endarterectomy and/or by-pass grafts, wedge resections, thoracotomy, formation of pacemaker pockets.
Urology: All applications including superficial urinary bladder tumors, invasive bladder carcinoma, urethral strictures, and lesions of the external genitalia (including condyloma acuminata).
Podiatry: Ablation, vaporization, incision, excision, and coagulation of soft tissue including matrixectomy, periungal and subungal warts, plantar warts, radical nail excision, and neurofibromas.
Product codes
GEX
Device Description
The CoolTouch Varia Laser System is an Nd:YAG laser producing laser emission at 1064 nm. The laser consists of a cabinet which houses the power supply, the cooling system, microcontroller, laser, foot switch, and the fiber optic for delivery of the laser energy with fiber optic handpiece setup.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues including skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands, hair follicles, vascular lesions, pigmented lesions, fine lines and wrinkles (Dermatology), soft tissue in endoscopic, laparoscopic surgery applications (Endoscopic/Laparoscopic General Surgery), soft tissue in the GI tract, esophageal neoplastic obstructions, varices, esophagitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, angiodysplasia, stomal ulcers, nonbleeding ulcers, gastric erosions, benign and malignant neoplasms, polyps, ulcer, colitis, and hemorrhoids (Gastroenterology), soft tissue in general surgery applications, skin incisions, tissue dissection, external tumors and lesions, internal organs, tumors, lesions, vessels (General Surgery), endometrial lining of the uterus, endometrial implants and/or peritoneal adhesions, cervix, submucous fibroids, benign endometrial polyps, uterine septum (Gynecology), soft tissue (Head and Neck/Otorhinolaryngology (ENT)), pituitary tumor, meningioma, hemagioblastoma, AVMs, glioma, glioblastoma, astrocytoma, oligodendroglioma (Neurosurgery), soft tissues in oculoplastic procedures such as operations on the lacrimal system, operations on the eyelids, biopsy or orbital tumors, eyeball, orbital contents (Oculoplastics), intra-articular tissue (Orthopedics), soft tissue (Plastic Surgery), pulmonary airway obstructions including squamous cell carcinoma, adenocarcinoma, carcinoid, benign tumors, granulomas, and benign strictures (Pulmonary/Thoracic Surgery), soft tissue, including lung tissue, vessels, wedge resections, pacemaker pockets (Thoracic Surgery), superficial urinary bladder tumors, invasive bladder carcinoma, urethral strictures, and lesions of the external genitalia (including condyloma acuminata) (Urology), soft tissue including matrixectomy, periungal and subungal warts, plantar warts, radical nail excision, and neurofibromas (Podiatry).
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)
Nonclinical Perfomance Data: None
Clinical Performance Data: None requested at this time.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
CoolTouch Varia Nd:YAG laser system, Patholase PinPointe FootLaser Nd:YAG laser system, Lumenis VersaPulse PowerSuite Ho:YAG/ Nd:YAG laser system
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
DEC 11 2009
Premarket Notification 510(k) Summary (As Required by 21 CFR 807.93)
This 510(k) Summary of safety and effectiveness for the New Star Model CoolTouch Varia Nd: YAG Surgical Laser system is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(en.sommary.
| Submitter: | New Star Lasers, Inc. d.b.a. CoolTouch, Inc. |
|---|---|
| Address: | 9085 Foothills Boulevard |
| Roseville, CA 95747 | |
| Contact Person: | Natalie Vollrath |
| Quality and Regulatory Manager | |
| Telephone/Fax/Email: | (916) 677-1912 - Phone |
| (916) 677-1901 - Fax | |
| nvollrath@newstarlasers.com - Email | |
| Date prepared: | September 24, 2009 |
| Device Trade Name: | CoolTouch Varia Nd:YAG Surgical Laser |
| Common Name: | Nd: YAG Surgical Laser |
| Classification Name: | Instrument, surgical, powered, laser |
| 79-GEX | |
| 21 CFR §878.4810 | |
| Legally Marketed Predicate | |
| Devices: | CoolTouch Varia Nd:YAG laser system Patholase PinPointe FootLaser Nd:YAG laser system Lumenis VersaPulse PowerSuite Ho:YAG/ Nd:YAG laser system |
| Device Description: | The CoolTouch Varia Laser System is an Nd:YAG laser |
| producing laser emission at 1064 nm. The laser consists of a | |
| cabinet which houses the power supply, the cooling system, | |
| microcontroller, laser, foot switch, and the fiber optic for | |
| delivery of the laser energy with fiber optic handpiece setup. | |
| Intended Use: | The soft tissue applications are for the coagulation, |
| photocoagulation, incision/excision, ablation, and | |
| vaporization of soft tissues including skin, cutaneous tissue, | |
| subcutaneous tissue, striated and smooth tissue, muscle, | |
| cartilage meniscus, mucous membrane, lymph vessels and | |
| nodes, organs and glands. |
Dermatology: For hair removal (destruction of hair follicles)
in all skin types and for coagulation and hemostasis of |
1
vascular lesions and soft tissue applications. In addition to the tissue types cited, pigmented lesions to reduce lesion size; for patients with lesions that would potentially benefit from aggressive treatment; for patients with lesions that have not responded to other laser treatments. Also for the treatment of fine lines and wrinkles.
Endoscopic/Laparoscopic General Surgery: Incision/excision and cutting, ablation, coagulation/hemostasis of soft tissue in endoscopic, laparoscopic surgery applications, including but not limited to cholecystectomy, appendectomy, vagotomy, and pyloromyotomy.
Gastroenterology: Tissue ablation and hemostasis in the Gl tract; esophageal neoplastic obstructions including squamous cell carcinoma and adenocarcinoma; GI hemostasis; including varices, esophagitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, angiodysplasia, stomal ulcers, nonbleeding ulcers, gastric erosions, GI tissue ablation, including benign and malignant neoplasms, angiodysplasia; polyps, ulcer, colitis, and hemorrhoids.
General Surgery: Soft tissue in general surgery applications, skin incisions, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors, lesions, tissue ablation, vessel coagulation.
Gynecology: Treatment of menorrhagia by photocoagulation of the endometrial lining of the uterus, ablation of endometrial implants and/or peritoneal adhesions, soft tissue excision procedures such as conization of the cervix, intrauterine gynecologic procedures where cutting, ablation and/or vessel coagulation may be indicated including submucous fibroids, benign endometrial polyps, uterine spetum.
Head and Neck/Otorhinolaryngology (ENT): Coagulation, photocoagulation, incision/excision, ablation, and vaporization of soft tissue.
Hemostasis during surgery: Adjunctive coagulation and hemostasis (control of bleeding) during surgery (endoscopic, laparoscopic, and open procedures).
Neurosurgery: Hemostasis of pituitary tumor, meningioma, hemagioblastoma, AVMs, glioma, glioblastoma, astrocytoma, oligodendroglioma.
2
Oculoplastics: Incision, excision, vaporization, ablation, and coagulation of soft tissues in oculoplastic procedures such as operations on the lacrimal system, operation on the eyelids, removal of biopsy or orbital tumors, enucleation of the eyeball, exteneration of orbital contents.
Orthopedics: Incision, excision, cutting, ablation and/or hemostasis of intra-articular tissue in orthopedic surgical and arthoscopic applications.
Plastic Surgery: Incision, excision, cutting, coagulation, and vaporization of soft tissue.
Pulmonary/Thoracic Surgery: Palliative treatment of benign and malignant pulmonary airway obstructions including squamous cell carcinoma, adenocarcinoma, carcinoid, benign tumors, granulomas, and benign strictures.
Thoracic Surgery: Incision, excision, cutting, coagulation, and vaporization of soft tissue, including lung tissue, in thoracic applications including but not limited to isolation of vessels for endarterectomy and/or by-pass grafts, wedge resections, thoractomy, formation of pacemaker pockets.
Urology: All applications including superficial urinary bladder tumors, invasive bladder carcinoma, urethral strictures, and lesions of the external genitalia (including condyloma accuminata).
Podiatry: Ablation, vaporization, incision, excision, and coagulation of soft tissue including matrixectomy, periungal and subungal warts, plantar warts, radical nail excision, and neromas.
The Cooltouch Varia has the same principle of operation, the same wavelength and essentially the same pulse energy rate as the predicate devices.
None
None
The CoolTouch Varia Nd:YAG Laser System is substantially equivalent to the predicate devices for the indications requested.
Additional Information:
Nonclinical Perfomance Data
Clinical Performance Data:
Comparison:
Conclusion:
None requested at this time.
3
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control·Room W-O66-0609 Silver Spring, MD 20993-0002
New Star Lasers, Inc d.b.a. CoolTouch, Inc. % Ms. Natalie R. Vollrath QA/RA Manager 9085 Foothills Boulevard Roseville, California 95747
DEC 1 I 2009
Re: K092964
Trade/Device Name: CoolTouch Varia Nd:YAG Laser System 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: September 24, 2009 Received: September 25, 2009
Dear Ms. Vollrath:
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
4
Page 2 - Ms. Natalie R. Vollrath
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 (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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sincerely yours,
Mark N. Melkerson
Director
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications For Use Statement
510(k) Number:
09296
Device Name:
CoolTouch Varia Nd: YAG Laser System
Indications for Use:
The soft tissue applications are for the coagulation, photocoagulation, incision/excision, ablation, and vaporization of soft tissues including skin, cutaneous tissue, subcutaneous tissue, strated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands.
Dermatology: For hair removal (destruction of hair follicles) in all skin types. For coagulation and hemostasis of vascular lesions and soft tissue applications. In addition to the tissue types. cited, pigmented lesions to reduce lesion size; for patients with lesions that would potentially benefit from aggressive treatment; for patients with lesions that have not responded to other laser treatments. Also for the treatment of fine lines and wrinkles.
Endoscopic/Laparoscopic General Surgery: Incision/excision and cutting, ablation, coagulation/hemostasis of soft tissue in endoscopic surgery applications, including but not limited to cholecystectomy, appendectomy, vagotomy, and pyloromyotomy.
Continued on next page
Prescription Use X (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)
Nixneogh far man
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K092964
Page _1_of _3
6
Indications for Use-Continued
Gastroenterology: Tissue ablation and hemostasis in the GI tract; esophageal neoplastic obstructions including squamous cell carcinoma and adenocarcinoma; G1 hemostasis; including varices, esophagitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, angiodysplasia, stomal ulcers, non-bleeding ulcers, gastric erosions, GI tissue ablation, including benign and malignant neoplasms, angiodysplasia; polyps, ulcer, colitis, and hemorrhoids.
General Surgery: Soft tissue in general surgery applications, skin incisions, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, turnors, lesions, tissue ablation, vessel coagulation.
Gynecology: Treatment of menorrhagia by photocoagulation of the endometrial lining of the uterus, ablation of endometrial implants and/or peritoneal adhesions, soft tissue excision procedures such as conization of the cervix, intra-uterine gynecologic procedures where cutting, ablation and/or vessel coagulation may be indicated including submucous fibroids, benign endometrial polyps, uterine spetum.
Head and Neck/Otorhinolaryngology (ENT): Coagulation, photocoagulation, incision/excision, ablation, and vaporization of soft tissue.
Hemostasis during surgery: Adjunctive coagulation and hemostasis (control of bleeding) during surgery (endoscopic, laparoscopic, and open procedures).
Neurosurgery: Hemostasis of pituitary tumor, meningioma, hemagioblastoma, AVMs, glioma, glioblastoma, astrocytoma, oligodendroglioma.
Oculoplastics: Incision, excision, vaporization, ablation, and coagulation of soft tissues in oculoplastic procedures such as operations on the lacrimal or son the eyelids, removal of biopsy or orbital tumors, enucleation of the eyeball, openation of orbital contents.
Orthopedics: Incision, excision, cutting, ablation and/or hemostasis of intra-articular tissue in orthopedic surgical and arthoscopic applications.
Plastic Surgery: Incision, excision, cutting, coagulation, and vaporization of soft tissue.
Pulmonary/Thoracic Surgery: Palliative treatment of benign and malignant pulmonary airway obstructions including squamous cell carcinoma, adenocarcinoma, carinoid, benignal vall wa granulomas, and benign strictures.
Thoracic Surgery: Incision, excision, cutting, coagulation, and vaporization of soft tissue, including lung tissue, in thoracic applications including but not limited to isol that of vessels for endarterectorny and/or by-pass grafts, wedge resections, thoractomy, formation of pacemaker pockets.
Nuhhpal Continued on next page
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K092964
Page_2_of_3
7
Indications for Use-Continued
Urology: All applications including superficial urinary bladder tumors, invasive bladder carcina, urethral strictures, and lesions of the external genitalia (including condyloma accuminata).
Podiatry: Ablation, vaporization, incision, excision, and coagulation of soft tissue including matrixectomy, periungal and subungal warts, plantar warts, radic insul excision, and neromas.
NuthRP ofh for mikn
(Division Sign-Off) Division of Surgical, Orthopedic, ana Restorative Devices
510(k) Number KD92964