(85 days)
The Protégé II Er:YAG Laser Systems and accessories are indicated for the surgical incision/excision, vaporization, ablation, and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, striated and smooth muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, agans and glands.
Dentistry: Soft tissue (incision, excision, ablation and coagulation)
Dermatology Plastic Surgery: Indications include epidermal nevi, clangiectasia, spider veins, actinic cheilitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision (including acne scars), debulking benign tumors and cysts, skin resurfacial skin lesions, and performing: diagnostic biopsies.
General Surgery: Indications include surgical incision, vaporization, ablation and coagulation of soft tissue where skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablation and/or vessel coagulation may be indicated.
Genitourinary: Indications include lesions of the external genitalia, urethra and anus, penis, scrown and uretira (includes condylomaacuminata, giant perineal condyloma and verrucous carcinoma), vulvar lesions, polyps and familial polyps of the colon.
Gynecology: Indications include cervical intracoithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts and condyloma.
Oral Maxillofacial: Indications include benign oral tumor, oral and glossal lesions and gingivectorny.
Otorhinolaryigology/Head and Neck (ENT): Indications include ear, nose and throat lesions, polyps, cysts, hyperkeratosis, excision of carcinogenic tissue and oral leukoplakia.
Ophthe mology: Indications include soft tissue surrounding the eye and orbit and anteriorcapsulotomy.
Podiatry: Indications include warts, plantar verrucae, large mosaic verrucae andmatrixectorny.
Arthrescopy: Including open and laparoscopic procedures
Orthopedic Surgery
Thoracic Surgery
Protégé II (tm) Er: YAG Laser System and Accessories (Upgrade)
The provided document set is a 510(k) premarket notification letter for the Protégé II (tm) Er: YAG Laser System and Accessories, dated July 3, 1998. This document confirms that the FDA has reviewed the submission and found the device substantially equivalent to a legally marketed predicate device.
However, the letter does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or multi-reader multi-case studies.
Therefore, I cannot provide the requested information from the given text. The letter primarily focuses on the regulatory approval of the device based on substantial equivalence, rather than detailing specific performance criteria or study results.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 3 | 1998
Marilyn M. Chou, Ph.D. Executive Vice President Convergent Laser Technologies a Subsidiary of Xintec Corporation 900 Alice Street Oakland, California 94607
- Re: K981627
Protégé II (tm) Er: YAG Laser System and Accessories Regulatory Class: II Product Code: GEX Dated: May 4, 1998 Received: May 7, 1998
Dear Dr. Chou:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submissions does not affect any obligation you might have under sections 531 through 542
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Page 2 - Dr. Marilyn M. Chou
of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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010014000
ﮐﮯ ﺳﺎﺗﮫ ﺳﺎ
S100k) Number: #K981627
Device Name: Protégé II (tm) Er: YAG Laser Systems and Accessories (Upgrade)
Indications For Use: The Protégé II Er:YAG Laser Systems and accessories are indicated for the surgical incision/excision, vaporization, ablation, and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, striated and smooth muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, agans and glands.
Dentistry: Soft tissue (incision, excision, ablation and coagulation)
Dermatology Plastic Surgery: Indications include epidermal nevi, clangiectasia, spider veins, actinic
- cheilitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision (including acne scars),
- debulking benign tumors and cysts, skin resurfacial skin lesions, and performing: diagnostic biopsies.
General Surgery: Indications include surgical incision, vaporization, ablation and coagulation of soft tissue where skin incision, tissue dissection, excision of external tumors and lesions,
- complete or partial resection of internal organs, tumors and lesions, tissue ablation and/or vessel coagulation may be indicated.
Genitourinary: Indications include lesions of the external genitalia, urethra and anus, penis, scrown and
· uretira (includes condylomaacuminata, giant perineal condyloma and verrucous carcinoma),
- vulvar lesions, polyps and familial polyps of the colon.
- Gynecology: Indications include cervical intracoithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts and condyloma.
Oral Maxillofacial: Indications include benign oral tumor, oral and glossal lesions and gingivectorny. Otorhinolaryigology/Head and Neck (ENT): Indications include ear, nose and throat lesions, polyps,
cysts, hyperkeratosis, excision of carcinogenic tissue and oral leukoplakia. Ophthe mology: Indications include soft tissue surrounding the eye and orbit and anteriorcapsulotomy. Podiatry: Indications include warts, plantar verrucae, large mosaic verrucae andmatrixectorny.
Arthrescopy: Including open and laparoscopic procedures
Orthopedic Surgery
Thoracic Surgery
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign Offi-
Divisior V
510(k) Number
Prescription Use
(21 CFR 801.109)
OR
Over-The-Counter Use
§ 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.