(90 days)
GEX
Not Found
No
The description focuses on the laser technology and its components, with no mention of AI or ML capabilities. The device is described as microprocessor-controlled, which is standard for many medical devices and does not imply AI/ML.
Yes.
The device is intended for surgical incision/excision, cutting, ablation, vaporization, and coagulation of soft tissue, which are all therapeutic procedures.
Yes
The intended use explicitly states "performing diagnostic biopsies" as one of the applications.
No
The device description clearly outlines hardware components including an optical delivery system, electronic power supply, interface circuitry, and an optical chamber containing a laser rod and cavity optics. It is a laser system, not software only.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the device is for "surgical incision/excision, cutting, ablation, vaporization, and coagulation of soft tissue." This describes a direct surgical intervention on living tissue within the body.
- Device Description: The device description details a laser system designed to deliver energy to the patient via an articulated arm and handpiece. This is consistent with a surgical laser, not a device that analyzes samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue biopsies after removal from the body), detecting analytes, or providing diagnostic information based on in vitro testing.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device performs a therapeutic or surgical function directly on the patient's body.
N/A
Intended Use / Indications for Use
The Fotona Novalis Er: Y AG Laser System and Accessories are intended for surgical incision/excision, cutting, ablation, vaporization, and coagulation of soft tissue. All soft tissue is included, such as, skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, meniscus, mucous membrane, lymph vessels and nodes, organs, and glands
DermatologyPlastic Surgery : epidermal nevi, telangiectasia, spider veins, actinic chellitis, keloids, 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 : surgical incision/excision, cutting, ablation, vaporization, 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 : Jesions of the external genitalia, urethra and anus, penis, scrotum and urethra, vulvar lesions, polyps and familial polyps of the colon
Gynecology : cerivecal intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts and condyloma
Oral/Maxillofacial : benign oral tumors, oral and glossal lesions and gingivectomy
Otorhinolaryngology/Head and Neck (ENT) : ear, nose and throat lesions, polyps, cysts, lyperkeratosis, excision of carcinogenic tissue and oral leukoplakia
Ophthalmology : soft tissue surrounding the eye and orbit anterior capsulotomy
Podiatry : warts, plantar vernicae, large mosaic verrucae and matrixectorny
Product codes
GEX
Device Description
The Fotona Novalis Er. YAG system ia a microprocessor controlled device which generates lascr light with a wavelongth of 2940 nm when used in conjunction with a host Novelis R system. When combined, the Er. YAG accessory and the host Ruby system constitute the Novalis RE laser system.
The Fotona Er. Y AG system is designed as an accessory for use with the Fotona Novalis R laser system "The Fir Y A ( suh-system is fincrionally integrated to the host laser system. When integrated, the host laser system recognizes the presence of the accessory and permits activation of the 2940 nm pulsed light via the same touchscreen as the host Ruby
The Novalis Er. YAG system is designed with 3 major sub-systems:
d) An optical dclivery system, interfacing the cncrgy from the lascr to the patient via an articulated arm and a focusing or collimated handpiece.
b) An electronic power supply and interfsce circuitry.
c) An optical chamber containing laser rod and laser cavity optics.
Accessories available for use with the Fotona Novalis Er: Y AG:
- Fotona SkinScan Scanning Device .
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, meniscus, mucous membrane, lymph vessels and nodes, organs, glands, epidermis, telangiectasia, spider veins, actinic chellitis, keloids, verrucae, skin tags, anal tags, keratoses, scars (including acne scars), benign tumors and cysts, superficial skin lesions, external tumors and lesions, internal organs, external genitalia, urethra, anus, penis, scrotum, vulvar lesions, polyps, familial polyps of the colon, cerivex, endometrial adhesions, condyloma, benign oral tumors, oral and glossal lesions, gingiva, ear, nose, throat, lyperkeratosis, carcinogenic tissue, oral leukoplakia, soft tissue surrounding the eye and orbit, anterior capsulotomy, warts, plantar vernicae, large mosaic verrucae.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Not Found
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
AUG 10 199
$$\ll \approx \ll 3\prime$$
Summary of Safety and Effectiveness Data Appendix E u
General Information and Description
The Fotona Novalis Er. YAG system ia a microprocessor controlled device which generates lascr light with a wavelongth of 2940 nm when used in conjunction with a host Novelis R system. When combined, the Er. YAG accessory and the host Ruby system constitute the Novalis RE laser system.
The Fotona Er. Y AG system is designed as an accessory for use with the Fotona Novalis R laser system "The Fir Y A ( suh-system is fincrionally integrated to the host laser system. When integrated, the host laser system recognizes the presence of the accessory and permits activation of the 2940 nm pulsed light via the same touchscreen as the host Ruby
The Novalis Er. YAG system is designed with 3 major sub-systems:
d) An optical dclivery system, interfacing the cncrgy from the lascr to the patient via an articulated arm and a focusing or collimated handpiece.
b) An electronic power supply and interfsce circuitry.
c) An optical chamber containing laser rod and laser cavity optics.
Accessories available for use with the Fotona Novalis Er: Y AG:
- Fotona SkinScan Scanning Device .
Summary of Substantial Equivalence
Fotona believes that its Novalis system is substantially equivalcnt to the Lascrscope Venus Erbium Laser System (EL Laser System) and to the Continuum Biomedical (Con-Bio) CB Erbium/2.94 Er: YAG Laser.
Both lasers are cleared for surgical incision, cutting, ablation, vaportzation, 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.
Technologically, the predicate devices have identical characteristics to the Novalis Er: Y AG laser, all three comprising an electronic control module and a flashlamp pumped Er. YAG laser rod generating light at a wavelength of 2.94 um, which is subsequently delivered to the patient via an articulated delivery arm and focusing or collimated handpiece.
The risk and benefits for the Fotona Novalis are comparable to the Laserscope Venus Laser System and Continuum Biomedical (Con-Bio) CB Erbium/2.94 Er: YAG Laser System when used for similar clinical applications.
It is therefore believed that there are no new questions of Safety or Effectiveness raised by the introduction of this device.
1
Image /page/1/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, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 10 1999
Ms. Mojca Valjavec, Dipl. Eng. Product Manager Lasers Division Fontona d.d. Stegne 7, 1210 Ljubljana, Slovenia
K991632 Re: K991634 Trade Name: Fontona NovalisR Ruby Laser System Fontona Novalis Er: YAG Laser System Regulatory Class: II Product Code: GEX Dated: May 3, 1999 Received: May 12, 1999
Dear Ms. Valjavec:
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 control provisions of the Act. The general control 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 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 regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your devices 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.
2
Page 2 – Ms. Mojca Valjavec, Dipl. Eng.
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 legally marketed predicate devices, results in a classification for your device and thus, permits your device 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) 594-4659. 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
Enclosures
3
APPENDIX F
Page I of 1
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name:
. 201
FOTONA NOVALIS Er: YAG LASER SYSTEM
Indications For Use:
The Fotona Novalis Er: Y AG Laser System and Accessories are intended for surgical incision/excision, cutting, ablation, vaporization, and coagulation of soft tissue. All soft tissue is included, such as, skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, meniscus, mucous membrane, lymph vessels and nodes, organs, and glands
DermatologyPlastic Surgery : epidermal nevi, telangiectasia, spider veins, actinic chellitis, keloids, 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 : surgical incision/excision, cutting, ablation, vaporization, 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 : Jesions of the external genitalia, urethra and anus, penis, scrotum and urethra, vulvar lesions, polyps and familial polyps of the colon
Gynecology : cerivecal intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts and condyloma
Oral/Maxillofacial : benign oral tumors, oral and glossal lesions and gingivectomy
Otorhinolaryngology/Head and Neck (ENT) : ear, nose and throat lesions, polyps, cysts, lyperkeratosis, excision of carcinogenic tissue and oral leukoplakia
Ophthalmology : soft tissue surrounding the eye and orbit anterior capsulotomy
Podiatry : warts, plantar vernicae, large mosaic verrucae and matrixectorny
(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) | X |
|---|---|
| ------------------------------------------ | --------------------------------------- |
OR
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K991632 |
| Over-The-Counter Use |
Premarket Notification for Fotona Novalis Fri VAC. I asar Custom