(70 days)
Not Found
Not Found
No
The document describes a laser system for surgical procedures and does not mention any AI or ML components.
Yes
The device is described as a "Laser System" and its intended uses include surgical procedures such as incision, vaporization, and coagulation of soft tissue for various medical indications across multiple specialties, which aligns with the definition of a therapeutic device.
No
The device is described as a laser system intended for "surgical incision, vaporization and coagulation of soft tissue," indicating its use in therapeutic and surgical procedures, not for identifying or predicting conditions.
No
The device description clearly outlines a physical laser system with hardware components like a console, power supplies, optical deck, cooling mechanism, keypad control panel, articulating arm, and handpiece adapters. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a surgical laser system for the incision, vaporization, and coagulation of soft tissue. This is a therapeutic and surgical application, not a diagnostic one.
- Device Description: The device description details a laser system with components for delivering laser energy to tissue. This aligns with a surgical device, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on the analysis of such samples.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device operates in vivo (within the body) for surgical procedures.
N/A
Intended Use / Indications for Use
The Laserscope Erbium: YAG Laser System and Accessories are indicated for use in procedures involving cutting (incision/excision), vaporizing and coagulating soft tissue.
All soft tissue is included such as skin, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands.
Clinical Applications:
Dermatology/Plastic Surgery General Surgery (Soft Tissue) Genitourinary Gynecology ENT Soft Tissue Procedures Oral and Maxillofacial Surgery Ophthalmology Podiatry
The Laserseope VELA Erbium: YAG Laser System and Accessories are intended for the surgical incision. vaporization and congulation of soft tissue. All soft tissue is included such as skin, subcutaneous tissue, striated and smooth tissue, muscle, cartilage menus membranc, lymph vessels and nodes, organs and glands.
DermatologyPlastic Surgery: Indications include, cpidcrmal nevi, teleagiestasia, soider veins, scinic chailitis, keloids, verrucee, skin togs, keratoses, sear revision, debulking banign tumors, decubitis ulcers and skin resurfacing.
General Surgery: The Erbium: YAG lass is intended for the surgical incision, vaportuation and coagulation of soft tissue during any general surgery application where skin incision, tissue of external lumors and lesions, complete or partial resection of internal organs, tissue abletion and/or vessel coagulation may be indicated.
Genitourinary: Indications include lesions of the external genitalia, welcon and anus, penis, scrown and urchire (includes condyloma acuminata, gian perined condyloma und verrucous carcinoma), valvar lesions, polyps and familial polyps of the colon.
Gynecology: Indications include cervical intraepithelial neoplusia (CDV), herpes simplex, endometrial adhesions, cysts and condyloms.
ENT: Indications include car, nose and throat lessions, polyps, cysts, hyperkeratosis; excision of carcinogenic lissue, oral leukoplakia.
Oral/Maxillofacial: Indications include benign oral tunnors, oral and glossel lessions and gingivectory.
Ophthalmology: Indications include soft tissue surrounding the eye and orbit and unterior capsulotomy.
Podiatry: Indications include warts, plantar verrucae, large mossic verrucae and matrixectory .
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Laserscope Erbium:YAG Laser System and Accessories consists of a moveable console containing power supplies, aiming and treatment lasers on a solid optical deck and a cooling mechanism to dissipate the heat generated by the system. A softouch keypad control panel with LCD displays enables the user to control the laser system operating parameters. The aiming beam is coincident with the Erbium:YAG beam and passes through an articulating arm. The aiming beam emerges at the distal end of a handpiece. Focusing handpiece adapters, which attach to the handpiece, are available in spot sizes of 1 - 8 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
All soft tissue is included such as skin, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands.
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.
The Continuum Biomedical CB Erbium/2.94 Er:YAG Laser System
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
K971843
JUL 23 1997
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS LASERSCOPE ERBIUM:YAG LASER SYSTEM AND ACCESSORIES
REGULATORY AUTHORITY:
Safe Medical Devices Act of 1990, 21 CFR 807.92
COMPANY NAME/CONTACT:
Lisa McGrath Laserscope 3052 Orchard Drive San Jose, CA 95134-2011 Phone: 408 943-0636 408 943-1454 FAX:
DEVICE TRADE NAME:
Laserscope Erbium:YAG Laser System and Accessories
DEVICE COMMON NAME:
Erbium:YAG Laser System
DEVICE DESCRIPTION:
10
The Laserscope Erbium:YAG Laser System and Accessories consists of a moveable console containing power supplies, aiming and treatment lasers on a solid optical deck and a cooling mechanism to dissipate the heat generated by the system. A softouch keypad control panel with LCD displays enables the user to control the laser system operating parameters. The aiming beam is coincident with the Erbium:YAG beam and passes through an articulating arm. The aiming beam emerges at the distal end of a handpiece. Focusing handpiece adapters, which attach to the handpiece, are available in spot sizes of 1 - 8 mm.
1
SUMMARY OF SAFETY AND EFFECTIVENESS, PAGE 2
DEVICE CLASSIFICATION:
Erbium:YAG Laser Systems and Accessories have not been specifically classified; however Nd:YAG, CO2, and Argon Surgical Lasers have been classified as Class II medical devices by the OB/GYN, General, Plastic Surgery and ENT Device Advisory Panels.
PERFORMANCE STANDARDS:
All Laserscope Erbium:YAG Surgical Laser Systems and Accessories conform with federal regulations and the performance standards 21 CFR 1040.10 and 1040.11 for medical laser systems.
INDICATION FOR USE STATEMENT:
The Laserscope Erbium: YAG Laser System and Accessories are indicated for use in procedures involving cutting (incision/excision), vaporizing and coagulating soft tissue.
All soft tissue is included such as skin, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands.
Clinical Applications:
Dermatology/Plastic Surgery General Surgery (Soft Tissue) Genitourinary Gynecology ENT Soft Tissue Procedures Oral and Maxillofacial Surgery Ophthalmology Podiatry
2
SUMMARY OF SAFETY AND EFFECTIVENESS, PAGE 3
COMPARISON WITH PREDICATE DEVICE:
The Laserscope Erbium:YAG Laser System and Accessories is substantially equivalent to the Continuum Biomedical CB Erbium/2.94 Er:YAG Laser System.
The risks and benefits for the Laserscope Erbium:YAG Laser System and Accessories are comparable to the predicate device when used for similar clinical applications.
Since the Laserscope Erbium:YAG Laser System and Accessories are substantially equivalent with respect to indications for use, materials, method of operation and physical construction to the predicate device, we believe it clearly meets the requirements for substantial equivalence according to Section 510(k) guidelines. Safety and effectiveness are reasonably assured, therefore justifying 510(k) clearance for commercial sale.
3
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lisa McGrath Sr. Regulatory Affairs Specialist Laserscope . . .. .. . . . . . . . . . . 3052 Orchard Drive San Jose, California 95134-2011
JUL 23 1997
Re: K971843
Trade Name: Laserscope VELA Erbium: YAG Laser System and Accessories Regulatory Class: II Product Code: GEX Dated: May 12, 1997 Received: May 14, 1997
Dear Ms. McGrath:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is 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 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device 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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
4
This letter will allow you to begin marketing your device as described in your 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 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 device, 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,
fo collafe
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
5
INDICATIONS FOR USE STATEMENT page I
510(k) Number:
971843
Device Name: . . . . . . _ .. .
Laserscope Erbium: YAG Laser. System and Accessorics . . . . . . . . . . . . .
Indications for Use:
The Laserseope VELA Erbium: YAG Laser System and Accessories are intended for the surgical incision. vaporization and congulation of soft tissue. All soft tissue is included such as skin, subcutaneous tissue, striated and smooth tissue, muscle, cartilage menus membranc, lymph vessels and nodes, organs and glands.
DermatologyPlastic Surgery: Indications include, cpidcrmal nevi, teleagiestasia, soider veins, scinic chailitis, keloids, verrucee, skin togs, keratoses, sear revision, debulking banign tumors, decubitis ulcers and skin resurfacing.
General Surgery: The Erbium: YAG lass is intended for the surgical incision, vaportuation and coagulation of soft tissue during any general surgery application where skin incision, tissue of external lumors and lesions, complete or partial resection of internal organs, tissue abletion and/or vessel coagulation may be indicated.
Genitourinary: Indications include lesions of the external genitalia, welcon and anus, penis, scrown and urchire (includes condyloma acuminata, gian perined condyloma und verrucous carcinoma), valvar lesions, polyps and familial polyps of the colon.
Gynecology: Indications include cervical intraepithelial neoplusia (CDV), herpes simplex, endometrial adhesions, cysts and condyloms.
ENT: Indications include car, nose and throat lessions, polyps, cysts, hyperkeratosis; excision of carcinogenic lissue, oral leukoplakia.
Oral/Maxillofacial: Indications include benign oral tunnors, oral and glossel lessions and gingivectory.
Ophthalmology: Indications include soft tissue surrounding the eye and orbit and unterior capsulotomy.
Podiatry: Indications include warts, plantar verrucae, large mossic verrucae and matrixectory .
Prescription Use
(Per 21 CFR 801.109)
bcsolles
gn-Off)
General Restorative Devices