(90 days)
K 951034
No
The description focuses on the hardware components and optical principles of a laser system, with no mention of AI, ML, or related concepts like image processing or data analysis for decision-making.
Yes
The device is used for the photocoagulation of benign vascular and pigmented lesions, which is a therapeutic intervention.
No
The device is indicated for photocoagulation of lesions, which is a treatment, not a diagnostic process.
No
The device description clearly outlines hardware components including an optical cavity, flashlamps, beamsplitter assembly, optical fiber delivery system, focusing handpiece, electronic power supply, interface circuitry, laser rod, and laser cavity optics. This is a hardware-based laser system with an accessory.
Based on the provided information, the Fotona Skinlight Plus Nd: YAG system is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "photocoagulation of benign vascular and pigmented lesions." This is a therapeutic procedure performed directly on a patient's body, not a test performed on a sample taken from the body (which is the definition of an in vitro diagnostic).
- Device Description: The description details a laser system that delivers light to tissue. This is consistent with a therapeutic device, not a diagnostic device that analyzes samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
Therefore, the Fotona Skinlight Plus Nd: YAG system is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Fotona Skinlight Plus Nd: YAG system is intended for the photocoagulation of benign vascular and pigmented lesions.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Fotona Skinlight Plus system is based on the addition of a Nd: YAG accessory to a previously cleared Er: YAG system (K962902). Within the accessory sub-system, an optical cavity contains the Nd: YAG crystal, which is activated by means of the use of flashlamps. After the cavity, a red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapuetic and aiming beams are guided down an optical fiber delivery system to a focusing handpiece. The laser is used in noncontact mode. The System is capable of emitting up to 2.0 Watts of light at 532 nm, with a minimal pulsewidth envelope of 100ms. The laser is intended to be used for the photocoagulation of benign vascular and pigmented lesions. The Nd: Y AG accessory sub-system is designed with 3 major sub-systems: a) An optical fiber delivery system terminated in spot-size specific handpiece. b) An electronic power supply and interface circuitry. c) An optical chamber containing laser rod and laser cavity optics. No accessories are available for use with the accessory Nd: Y AG sub-system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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.
K 951034
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.
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
SEP 2 3 1997
Premarket notification : Fotona Nd: YAG Laser
972368
Summary of Safety and Effectiveness Data Appendix E :
General Information and Description
The Fotona Skinlight Plus system is based on the addition of a Nd: YAG accessory to a previously cleared Er: YAG system (K962902). Within the accessory sub-system, an optical cavity contains the Nd: YAG crystal, which is activated by means of the use of flashlamps. After the cavity,a red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapuetic and aiming beams are guided down an optical fiber delivery system to a focusing handpiece. The laser is used in noncontact mode.
The System is capable of emitting up to 2.0 Watts of light at 532 nm, with a minimal pulsewidth envelope of 100ms. The laser is intended to be used for the photocoagulation of benign vascular and pigmented lesions.
The Nd: YAG accessory sub-system is designed with 3 major sub-systems:
a) An optical fiber delivery system terminated in spot-size specific handpiece.
b) An electronic power supply and interface circuitry.
c) An optical chamber containing laser rod and laser cavity optics.
No accessories are available for use with the accessory Nd: Y AG sub-system.
Summary of Substantial Equivalence
Fotona believes that its Skinlight Plus Nd: Y AG system is substantially equivalent to the Laserscope Aura system, previously cleared under K 951034.
The Fotona Skinlight Plus Nd: YAG system is intended for the photocoagulation of benign vascular and pigmented lesions. It therefore has the same Intended Use as the Laserscope Aura system.
Both of these lasers have a wavlength of 532nm. This wavelength is highly absorbed in soft tissue containing blood or melanin. Both lasers are therefore absorbed in an equally small volume of tissue, allowing for very precise action on the target tissue components.
Both lasers have a maximum average power capability of 10 Watts.
In terms of pulsewidth, both systems generate an envelope containing a series of individual pulses. In each case, an envelope width of 0.1 - 1.0 seconds may be preset. The envelope may also be extended to a continuous emission.
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 Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol that resembles a human figure or a caduceus, possibly representing health and well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Fotona c/o Iain D. Miller, Ph.D. President Medical Laser Solutions 304 Newbury Street, #339 Boston, Massachusetts 02115
SEP 2 3 1997
Re: K972368
Trade Name: Fotona Skinlight Plus Nd: YAG System Regulatory Class: II Product Code: GEX Dated: June 23, 1997 Received: June 25, 1997
Dear Dr. Miller:
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
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Page 2 - Iain D. Miller, Ph.D.
devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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,
S.J.M. Witt, Ph.D., M.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
3
Appendix F
Page_
510(k) Number (if known):K972369 Skinlight Plus Nd : YAG system Device Name: otona
Indications For Use:
The Fotona Skinlight Plus Nd: YAG system is indicated for the photocoagulation of benign vascular and pigmented lesions.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division) Sign-Off) | |
| Division of General Restorative Devices | KG 72368 |
| 510(k) Number |
Prescription Use /
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)