(62 days)
No
The document does not mention AI, ML, or any related technologies in the intended use, device description, or performance studies sections.
Yes
The device is indicated for a wide range of medical treatments including the treatment of various lesions, removal of unwanted hair for medical reasons (pseudofolliculitis barbae), general surgical applications, and treatments for several medical conditions across various specialties like gastroenterology, gynecology, neurosurgery, and urology, all of which fall under therapeutic interventions.
No
The device is indicated for various treatment procedures (e.g., hair removal, treatment of lesions, surgical applications), not for diagnosing conditions.
No
The device description explicitly states it consists of laser and IPL systems, which are hardware-based medical devices. The intended use also describes procedures performed with these hardware systems.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This testing is performed outside of the body (in vitro).
- Device Function: The NaturaLight IPL System and NaturaLase LP Laser System are used for direct treatment of the body through the application of light and laser energy. Their intended uses involve procedures like hair removal, treatment of skin lesions, surgical applications, and more. These are all in vivo (within the body) procedures.
- Lack of Specimen Analysis: The descriptions do not mention the analysis of any biological specimens.
Therefore, the NaturaLight IPL System and NaturaLase LP Laser System fall under the category of therapeutic or surgical devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
NaturaLight IPL System and the NaturaLase LP+ System when used in IPL (intense pulsed light) Mode is indicated for: Dermatology/Plastic Surgery: The removal of unwanted hair from skin types I-VI, and to effect stable long-term, or permanent, hair reduction. The treatment of benign pigmented lesions, including lentigines, nevi, melasma, and cafe-au-lait. treatment of vascular lesions, including port wine stains, hemangiomas, angiomas, telangiectasias, rosacea, facial and leg veins.
The Focus Medical NaturaLase LP Laser System and the NaturaLase LP+ System when used in Laser Mode is indicated for: General Surgical Applications: Incision, excision, coagulation, hemostasis, vaporization, and/or ablation of soft tissue in dermatology/plastic surgery, endoscopic/laparoscopic general surgery, gastroenterology, general surgery, gynecology, head and neck/ otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary surgery, thoracic surgery, and urology. Dermatology/Plastic Surgery: Coagulation and hemostasis of benign vascular lesions such as port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg and spider veins. In addition, the NaturaLase LP is intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, schorrheic keratoses, nevi chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques. The Natural ase I.P Laser is also indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. Cutting, incision, excision, hemostasis, coagulation, vaporization and ablation of soft tissue in dermatology and plastic surgery. The NaturaLase LP Laser is also indicated for the treatment of facial wrinkles and wrinkles such as, but not limited to, periocular and periorbital wrinkles. The NaturaLase LP Laser is indicated for the removal of unwanted hair, for the stable long tem, or permanent, hair reduction through sclective targeting of melanin in hair follicles, and for the treatment for pscudofolliculitis barbae (PFB). The NaturaLase LP Laser is indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. The Natural asc LP Laser is indicated for use on all skin types (Fitzpatrick I - VI) including tanned skin. Endoscopic/Laparoscopic Surgery: The NaturaLase Ll' Laser is also indicated for use in a variety of surgical procedures in several surgical specialties. These include, but not limited to, cholccystectomy, appendectorny, vagotomy, and pyloromyomotomy where its abilities to incisc, excise, coagulate, vaporize, or ablate soft tissue may be applied. Gastroenterology: Tissue ablation and hemostasis in the gastrointestinal tract; esophagea' neoplasic obstruction including squamous cell carcinoma and adenocarcinoma, gastrointestina! hemostasis including varices, esophagitis, esophageal ulcer, Mallory-Weiss tear, gastric angiodysplasia, stomal ulcers, non-bleeding ulcers, gastric erosions, ulcer. gastrointestinal tissue ablation including benign and malignant neoplasm, angiodysplasia, polyps, ulcer, colitis, and hemorrhoids. General Surgery: Incision, excision, vaporization, ablation, and hemostasis of soft tissue 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, tonsillectomy, and hemorrhoids. Gynecology: Treatment of menorrhagia by photocoagulation of the endometrial lining of the uterus, ablation of endometrial implants and/or peritoneal adhesions, soft tissue excisional procedures such as excisional conization of the cervix, intrauterine gynecologic procedures where cutting, ablation, and/or vessel coagulation may be indicated including submucous fibroids, benign endometrial polyps, and uterine septum. Head and Neck/Otorhinolaryngology (ENT): Tissue incision, excision, ablation, and vessel hemostasis. Hemostasis During Surgery: Adjunctive coagulation and hemostasis (bleeding control) during surgery in endoscopic (e.g. laparoscopic) and open procedures. Neurosurgery: Hemostasis for pituitary tumor, meningioma, hemagioblastoma, AVMs. glioblastoma, astrocytoma, oligodendroglioma. Oculoplastics: Incision, excision, vaporization, and/or coagulation of tissues in oculoplastic procedures such as operations on the lacrimal system, operation on the eyelids, removal of biopsy or orbital tumors, enucleation on eyeball, exteneration of orbital contents. Orthopedics: Cutting, ablation, and/or hemostasis of intra-articular tissue in orthopedic surpical and arthroscopic applications. Pulmonary Surgery: Palliative treatment of benign and malignant pulmonary airway obstructions, including squamous cell carcinoma, adenocarcinoma, carcinoid, benign tumors, granulomas, and benign strictures. Thoracic Surgery: Cutting (incision/excision), coagulating, and vaporization of soft tissue. Thoracic applications including, but not limited to, isolation of vessels for endarterectomy and/or by-pass grafts, wedge resections, thoractomy, formation of pacemaker pockets; vaporization, coagulation, incision/excision, debulking, and ablation of lung tissue (thoracoscopy). Urology: All applications including superficial urinary bladder tumors, invasive bladder carcinoma, urethral strictures and lesions of the external genitalia (including condyloma acuminata).
Product codes
GEX
Device Description
The Focus Medical NaturaLase LP and NaturaLight Family of Products consists of the NaturaLase LP Nd: YAG Laser System, the NaturaLight IPL System and the NaturaLase LP+ a simple combination of the NaturaLase LP and the NaturaLight.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin, gastrointestinal tract, uterus, head and neck, brain, eye area, joints, pulmonary airways, thoracic area, urinary bladder, urethra, external genitalia.
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)
K033549, K030527, K020839, K031828
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
K041829 1 of 4
Section 10 510(k) Sun mary
This 510(k) summary of safety and effectiveness for the Focus Medical NaturaLase LP and NaturaLight Family of Products is submitted in accordance with the requirements of SMDA 1990 and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.
Applicant: Focus Medical
SEP - 7 2004
Address: Focus Medical, LLC 23 Francis J. Clarke Circle Bethel, CT 06801
Contact Person: Mr. John B. Lee, Jr. President Focus Medical
Telephone: 203-730-8885
Preparation Date: June 2004 (of the Summary)
Device Name: NaturaLase LP and NaturaLight Family of Products
Common Name: Nd:YAG and Intense Pulsed Light treatment system
Classification: Laser surgical instrument for use in general and plastic surgery and in dermatology.
Class II medical device 21CFR 878.4810 Product Code: GEX Panel: 79
Predicate devices: Palomar Starlux Pulsed Light System (K033549) Lumcnis Family of Intense Pulsed Light (IPL) and IPL/Nd: YAG Laser Systems (K030527) I umenis IPI. Quantum Family of Products (K020839) Focus Medical NaturaLase LP (K031828)
1
NaturaLase LP and NaturaLight Family of Products 510(k) Submission
K041829 2 of 4
Device description:
The Focus Medical NaturaLase LP and NaturaLight Family of Products consists of the NaturaLase LP Nd: YAG Laser System, the NaturaLight IPL System and the NaturaLase LP+ a simple combination of the NaturaLase LP and the NaturaLight.
Indications for Use:
NaturaLight Indications for Use
NaturaLight IPL System and the NaturaLase LP+ System when used in IPL (intense pulsed light) Mode is indicated for:
Dermatology/Piastic Surgery:
The removal of unwanted hair from skin types I-VI, and to effect stable long-term, or permanent, hair reduction.
The treatment of benign pigmented lesions, including lentigines, nevi, melasma, and cafe-au-lait. treatment of vascular lesions, including port wine stains, hemangiomas, angiomas, telangiectasias, rosacea, facial and leg veins.
NaturaLase LP Indications For Use
The Focus Medical NaturaLase LP Laser System and the NaturaLase LP+ System when used in Laser Mode is indicated for:
General Surgical Applications:
Incision, excision, coagulation, hemostasis, vaporization, and/or ablation of soft tissue in dermatology/plastic surgery, endoscopic/laparoscopic general surgery, gastroenterology, general surgery, gynecology, head and neck/ otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary surgery, thoracic surgery, and urology.
Dermatology/Plastic Surgery:
Coagulation and hemostasis of benign vascular lesions such as port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg and spider veins. In addition, the NaturaLase LP is intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, schorrheic keratoses, nevi chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques. The Natural ase I.P Laser is also indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
Cutting, incision, excision, hemostasis, coagulation, vaporization and ablation of soft tissue in dermatology and plastic surgery.
The NaturaLase LP Laser is also indicated for the treatment of facial wrinkles and wrinkles such as, but not limited to, periocular and periorbital wrinkles.
The NaturaLase LP Laser is indicated for the removal of unwanted hair, for the stable long tem, or permanent, hair reduction through sclective targeting of melanin in hair follicles, and for the treatment for pscudofolliculitis barbae (PFB).
2
The NaturaLase LP Laser is indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. The Natural asc LP Laser is indicated for use on all skin types (Fitzpatrick I - VI) including tanned skin.
Endoscopic/Laparoscopic Surgery:
The NaturaLase Ll' Laser is also indicated for use in a variety of surgical procedures in several surgical specialties. These include, but not limited to, cholccystectomy, appendectorny, vagotomy, and pyloromyomotomy where its abilities to incisc, excise, coagulate, vaporize, or ablate soft tissue may be applied.
Gastroenterology:
Tissue ablation and hemostasis in the gastrointestinal tract; esophagea' neoplasic obstruction including squamous cell carcinoma and adenocarcinoma, gastrointestina! hemostasis including varices, esophagitis, esophageal ulcer, Mallory-Weiss tear, gastric angiodysplasia, stomal ulcers, non-bleeding ulcers, gastric erosions, ulcer. gastrointestinal tissue ablation including benign and malignant neoplasm, angiodysplasia, polyps, ulcer, colitis, and hemorrhoids.
General Surgery:
Incision, excision, vaporization, ablation, and hemostasis of soft tissue 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, tonsillectomy, and hemorrhoids.
Gynecology:
Treatment of menorhagia by photocoagulation of the endometrial lining of the uterus, ablation of endometrial implants and/or peritoneal adhesions, soft tissue excisional procedures such as excisional conization of the cervix, intrauterine gynecologic procedures where cutting, ablation, and/or vessel coagulation may be indicated including submucous fibroids, benign endometrial polyps, and uterine septum.
Head and Neck/Otorhinolaryngology (ENT):
Tissue incision, excision, ablation, and vessel hemostasis.
Hemostasis During Surgery:
Adjunctive coagulation and hemostasis (bleeding control) during surgery in endoscopic (e.g. laparoscopic) and open procedures.
Neurosurgery:
Hemostasis for pituitary tumor, meningioma, hemagioblastoma, AVMs. glioblastoma, astrocytoma, oligodendroglioma.
Oculoplastics:
Incision, excision, vaporization, and/or coagulation of tissues in oculoplastic procedures such as operations on the lacrimal system, operation on the eyelids, removal of biopsy or orbital tumors, enucleation on eyeball, exteneration of orbital contents.
3
NaturaLase LP and NaturaLight Family of Products 510(k) Submission
K041829 4 of 4
Orthopedics:
Cutting, ablation, and/or hemostasis of intra-articular tissue in orthopedic surpical and arthroscopic applications.
Pulmonary Surgery:
Palliative treatment of benign and malignant pulmonary airway obstructions, including squamous cell carcinoma, adenocarcinoma, carcinoid, benign tumors, granulomas, and benign strictures.
Thoracic Surgery:
Cutting (incision/excision), coagulating, and vaporization of soft tissue. Thoracic applications including, but not limited to, isolation of vessels for endarterectomy and/or by-pass grafts, wedge resections, thoractomy, formation of pacemaker pockets; vaporization, coagulation, incision/excision, debulking, and ablation of lung tissue (thoracoscopy).
Urology:
All applications including superficial urinary bladder tumors, invasive bladder carcinoma, urethral strictures and lesions of the external genitalia (including condyloma acuminata).
4
Image /page/4/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, with three parallel lines forming a stylized staff and a pair of intertwined snakes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 7 2004
Mr. John B. Lee, Jr. President Focus Medical, LLC 23 Francis J Clarke Circle Bethel, Connecticut 06801
Re: K041829
Trade/Device Name: NaturaLase LP and NaturaLight Family of Products Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: July 7, 2004 Received: July 12, 2004
Dear Mr. Lee:
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 such additional controls. Existing major regulations affecting your device can he 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 and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.
5
Page 2 - Mr. John B. Lee, Jr.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known):K041829
Device Name:
Indications For Use:
NaturaLight IPL System (intense pulsed light) is indicated for: The removal of unwanted hair from skin types I-VI, and to effect stable long-term, or permanent, hair reduction. The treatment of benign pigmented lesions, including
lentigines, nevi, melasma, and cafe-au-lait. treatment of vascular lesions, including port wine stains, hemangiomas, telangiectasias, rosacea, facial and leg veins.
NaturaLase LP Indications For Use
The Focus Medical NaturaLase LP Laser System and the NaturaLase LP+ System when used in Laser Mode is indicated for:
General Surgical Applications:
Incision, excision, coagulation, hemostasis, vaporization, and/or ablation of soft tissue dermatology/plastic surgery, endoscopic/laparoscopic general surgerv. in gastroenterology, general surgery, gynecology, head and neck/ otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary surgery, thoracic surgery, and urology.
× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
Sion Sign-Off Division of General, Restorative, and Neurological Devices
Page 1 of 4
510(k) Number K04/829
7
Continuation for Indications for Use on Form FDA 3514 Section G Page 2
Dermatology/Plastic Surgery:
Coagulation and hemostasis of benign vascular lesions such as port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg and spider veins. In addition, the NaturaLase LP is intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques. The NaturaLase LP Laser is also indicated for pigmented lesions to reduce lesion size,
for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
Cutting, incision, excision, hemostasis, coagulation, vaporization and ablation of soft tissue in dermatology and plastic surgery.
The NaturaLase LP Laser is also indicated for the treatment of facial wrinkles and wrinkles such as, but not limited to, periocular and periorbital wrinkles.
The NaturaLase LP Laser is indicated for the removal of unwanted hair, for the stable long tem, or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudofolliculitis barbae (PFB).
The NaturaLase LP Laser is indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
The NaturaLase LP Laser is indicated for use on all skin types (Fitzpatrick I - VI) including tanned skin.
Endoscopic/Laparoscopic Surgery:
The Natural.ase LP Laser is also indicated for use in a variety of surgical procedures in several surgical specialties. These include, but not limited to, cholecystectomy, appendectomy, vagotomy, and pyloromyomotomy where its abilities to incise, excise, coagulate, vaporize, or ablate soft tissue may be applied.
Over-The-Counter Use AND/OR Prescription Use X (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Meriam C. Provost
(Division Six, O.C.)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 2 of 4
510(k) Number K041829
8
Gastroenterology:
Tissue ablation and hemostasis in the gastrointestinal tract; esophageal neoplastic obstruction including squamous cell carcinoma and adenocarcinoma, gastrointestinal hemostasis including varices, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, angiodysplasia, stomal ulcers, non-bleeding ulcers, gastric erosions, gastrointestinal tissue ablation including benign and malignant neoplasm, angiodysplasia, polyps, ulcer, colitis, and hemorrhoids.
General Surgery:
Incision, excision, vaporization, ablation, and hemostasis of soft tissue general surgery applications, skin incisions, tissue dissection, excision of external turnors and lesions, complete or partial resection of internal organs, tumors, lesions, tissue ablation, vessel coagulation, tonsillectomy, and hemorrhoids.
Gynecology:
Treatment of menorrhagia by photocoagulation of the endometrial lining of the uterus. ablation of endometrial implants and/or peritoneal adhesions, soft tissue excisional procedures such as excisional conization of the cervix, intrauterine gynecologic procedures where cutting, ablation, and/or vessel coagulation may be indicated including submucous fibroids, benign endometrial polyps, and uterine septum.
Head and Neck/Otorhinolaryngology (ENT):
Tissue incision, excision, ablation, and vessel hemostasis.
Hemostasis During Surgery:
Adjunctive coagulation and hemostasis (bleeding control) during surgery in endoscopic (e.g. laparoscopic) and open procedures.
Neurosurgery:
Hemostasis for pituitary tumor, meningioma, hemagioblastoma, AVMs. glioblastoma, astrocytoma, oligodendroglioma.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K041829
9
Continuation for Indications for Use on Form FDA 3514 Section G Page 4
Oculoplastics:
Incision, excision, vaporization, and/or coagulation of tissues in oculoplastic procedures such as operations on the lacrimal system, operation on the eyelids, removal of biopsv or orbital tumors, enucleation on eyeball, exteneration of orbital contents.
Orthopedics:
Cutting, ablation, and/or hemostasis of intra-articular tissue in orthopedic surgical and arthroscopic applications.
Pulmonary Surgery:
Palliative treatment of benign and malignant pulmonary airway obstructions, including squamous cell carcinoma, adenocarcinoma, carcinoid, benign tumors, granilo mas, and benign strictures.
Thoracic Surgery:
Cutting (incision/excision), coagulating, and vaporization of soft tissue. Thoracic applications including, but not limited to, isolation of vessels for endarterectomy and/or by-pass grafts, wedge resections, thoractomy, formation of pacemaker pockets, vaporization, coagulation, incision/excision, debulking, and ablation of lung tissue (thoracoscopy).
Urology:
All applications including superficial urinary bladder tumors, invasive bladder carcinoma, urethral strictures and lesions of the external genitalia (including condyloma acuminata).
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provot (Division Sign-Off) Division of General, Restorative. and Neurological Devices
Page 4 of 4
510(k) Number k04/821