(86 days)
Not Found
No
The description focuses on the physical components and controls of a laser system for soft tissue procedures, with no mention of AI or ML capabilities.
No.
The device is used for cutting, vaporizing, ablation, and coagulation of soft tissue, which are surgical procedures, not therapeutic ones.
No
The device is indicated for surgical procedures involving cutting, vaporizing, ablation, and coagulation of soft tissue, which are therapeutic functions, not diagnostic ones.
No
The device description clearly outlines a physical console containing power supplies, lasers, a cooling mechanism, an articulated arm, and handpieces with removable tips. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes procedures involving cutting, vaporizing, ablation, and coagulation of soft tissue within the body. IVD devices are used to examine specimens from the body (like blood, urine, tissue samples) in vitro (outside the body) to diagnose or monitor conditions.
- Device Description: The description details a laser system designed for surgical procedures, including an articulated arm and handpieces for direct application to tissue. This is consistent with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
Therefore, the Laserscope EL Laser System and Accessories is a surgical laser system, not an IVD.
N/A
Intended Use / Indications for Use
The Laserscope EL Laser System and Accessories is indicated for use in procedures involving cutting (incision/excision), vaporizing, ablation and coagulation of soft tissue.
All soft tissue is included such as skin, cutaneous tissue, 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
Genitourinary
Gynecology
Oral and Maxillofacial
Otorhinolaryngology/Head and Neck (ENT)
Ophthalmology
Podiatry
Product codes
GEX
Device Description
The Laserscope EL 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 svstem.
The entire laser unit and controls are contained in a single console. This console is electrically connected to the facility's power source. Emission of the laser beam is through an anodized aluminum articulated arm. The articulated arm is positioned at the left, upper part of the device and is not removable by the customer. Handpieces with removable, sterilizable tips, are available in 1, 3, 5 and 7 mm spotsizes.
The user interface consists of an LCD which displays laser parameters, data on connected devices and information on messages and prompts. Located on the front panel are four knobs enabling the user to select laser settings, and a READY/STANDBY button for selecting READY or STANDBY mode. An on/off keyswitch turns the laser system on and off. An emergency shut off button disables the laser and places the laser system in a holding status.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands.
Specific examples include: epidermal nevi, telangiectasia, spider veins, actinic chellitis, keloids, verrucae, skin tags, anal tags, keratoses, acne scars, benign tumors and cysts, superficial skin lesions, lesions of the external genitalia, urethra, anus, penis, scrotum, vulva, polyps, familial polyps of the colon, cervical intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, benign oral tumors, oral and glossal lesions, gingiva, ear, nose and throat lesions, polyps, cysts, hyperkeratosis, carcinogenic tissue, oral leukoplakia, soft tissue surrounding the eye and orbit, anterior capsulotomy, warts, plantar verrucae, large mosaic verrucae.
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)
Laserscope Erbium: YAG Laser System and Accessories, Continuum Biomedical CB Erbium/2.94TM Erbium:YAG Laser, Schwartz Electro-Optics, Inc. CLR 2940 Erbium CrystaLase, Coherent UltraFine™ Erbium Laser
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
K47496
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS LASERSCOPE EL LASER SYSTEM AND ACCESSORIES
REGULATORY AUTHORITY:
Safe Medical Devices Act of 1990, 21 CFR 807.92
COMPANY NAME/CONTACT:
Golff ANT In Lack H. Hardtman Laserscope 3052 Orchard Drive San Jose, CA 95134-2011 Phone: 408 943-0636 408 943-1454 FAX:
DEVICE TRADE NAME:
Laserscope EL Laser System and Accessories
DEVICE COMMON NAME:
Erbium:YAG Laser System
DEVICE DESCRIPTION:
The Laserscope EL 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 svstem.
The entire laser unit and controls are contained in a single console. This console is electrically connected to the facility's power source. Emission of the laser beam is through an anodized aluminum articulated arm. The articulated arm is positioned at the left, upper part of the device and is not removable by the customer. Handpieces with removable, sterilizable tips, are available in 1, 3, 5 and 7 mm spotsizes.
The user interface consists of an LCD which displays laser parameters, data on connected devices and information on messages and prompts. Located on the front panel are four knobs enabling the user to select laser settings, and a READY/STANDBY button for selecting READY or STANDBY mode. An on/off keyswitch turns the laser system on and off. An emergency shut off button disables the laser and places the laser system in a holding status.
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 J classified as Class II medical devices by the OB/GYN, General, Plastic Surgery and ENT Device Advisory Panels.
PERFORMANCE STANDARDS:
The Laserscope EL Surgical Laser System and Accessories conforms with federal regulations and the performance standards 21 CFR 1040.10 and 1040.11 for medical laser systems.
INDICATION FOR USE STATEMENT:
The Laserscope EL Laser System and Accessories is indicated for use in procedures involving cutting (incision/excision), vaporizing, ablation and coagulation of soft tissue.
All soft tissue is included such as skin, cutaneous tissue, 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 Genitourinary Gynecology Oral and Maxillofacial Otorhinolaryngology/Head and Neck (ENT) Ophthalmology Podiatry
2
SUMMARY OF SAFETY AND EFFECTIVENESS, PAGE 3
COMPARISON WITH PREDICATE DEVICE:
The Laserscope EL Laser System and Accessories is substantially equivalent to the Laserscope Erbium: YAG Laser System and Accessories, the Continuum Biomedical CB Erbium/2.94TM Erbium:YAG Laser, the Schwartz Electro-Optics, Inc. CLR 2940 Erbium CrystaLase, and the Coherent UltraFine™ Erbium Laser.
The risks and benefits for the Laserscope EL Laser System and Accessories are comparable to the predicate devices when used for similar clinical applications.
Since the Laserscope EL Laser System and Accessories is 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) quidelines. Safety and effectiveness are reasonably assured, therefore iustifying 510(k) clearance for commercial sale.
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 stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circle's perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 7 1998
Mr. Paul H. Hardiman Manager Regulatory Affairs/Clinical Affairs Laserscope 3052 Orchard Drive 95134-2011 San Jose, California
K974896 Re : Laserscope EL Laser System and Accessories Trade Name: Regulatory Class: II Product Code: GEX December 29, 1997 Dated: Received: December 31, 1997
Dear Mr. Hardiman:
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 requirement, 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 requlation may result in regulatory In addition, FDA may publish further announcements action. 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
Page 2 - Mr. Hardiman
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,
Celia M. Witten, Ph.D.
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 1
510(k) Number.
974896
Device Name:
Laserscope EL Laser System and Accessories
Indications for Use:
The Laserscope EL Laser System and Accessories are intended for the surgical incision/excision. vaporization, ablation and coagulation of soft tissue is included, such as, skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartliage meniscus, mucous membrane, lymph vessels and nodes, organs and glands.
Dermatology/Plastic Surgery: Indications include epidermal nevi, telangiectasia, spider veins, actinic chellitis, kelolds, verrucae, skin tags, anal tags, keratoses, scar revision (including acne scars), debulking benign tumors and cysts, skin resurfacing, superficial 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, turnors and lesions, tissue ablation and/or vessel coagulation may be indicated.
Genitourinary: indications include lesions of the external genitalia, urethra and anus, penis, scrotum and urethra (includes condyloma acuminata, giant perineal condytoma and verrucous carcinoma), vulvar lesions, polyps and familial polyps of the colon.
Gynecology. Indications include cervical intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts and condyloma
Oral/Maxillofacial: Indications include benign oral tumors, oral and glossal lesions and gingivectorny.
Otorhinolaryngology/Head and Neck (ENT): Indications include ear, nose and throat lesions, polyps, cysts, hyperkeratosis; excision of carcinogenic tissue and oral leukoplakia.
Ophthalmology: Indications include soft tissue surrounding the eye and orbit and anterior capsulotomy.
Podiatry: Indications include warts, plantar verrucae, large mosaic verrucae and matrixectomy.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(per 21 CFR 801.109)
Over-The-Counter Use
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(Division Sign-Offm
Division of General Restorative Devices K974896
510(k) Number