(84 days)
Not Found
No
The device description focuses on the hardware components and basic microprocessor control for parameter selection, with no mention of AI or ML capabilities.
Yes
The device is intended for medical purposes such as coagulation, haemostasis of vascular lesions, and treatment of facial wrinkles, which are therapeutic applications.
No.
The device's stated intended uses are for coagulation and haemostasis of vascular lesions, removal and permanent reduction of unwanted hair, and non-invasive treatment of facial wrinkles. These are all therapeutic or cosmetic procedures, not diagnostic ones.
No
The device description clearly outlines multiple hardware components including a laser rod, power supply, cooling system, and optical delivery system. While it mentions a microprocessor-based controller, this is part of a larger hardware system, not a standalone software device.
Based on the provided information, the DEPILASE TWIN YAG Laser System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the device is for procedures performed on the patient (coagulation, haemostasis, hair removal, wrinkle treatment). IVD devices are used to examine specimens from the body (like blood, urine, tissue) to diagnose or monitor conditions.
- Device Description: The description details a laser system that delivers energy to the patient's skin. This is consistent with a therapeutic or cosmetic device, not a diagnostic one that analyzes biological samples.
- 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 DEPILASE TWIN YAG Laser System is a medical device used for therapeutic and cosmetic applications, not an IVD.
N/A
Intended Use / Indications for Use
The DEPILASE TWIN YAG Laser System is indicated for the use in dermatological applications for the non invasive treatment of facial wrinkles ( 1064 nm laser emission).
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The DEPILASE TWIN YAG Laser System is based on Nd: YAG laser technology. Within the system, an optical cavity contains the Nd: YAG crystal, which is activated by means of the use of a flashlamp, with the option of frequency doubling the fundamental laser wavelength, from 1064 nm to 532 nm. The frequency doubling wavelength is obtained by passing with the laser radiation through a special crystal called Second Harmonic Crystal (SHC). After the cavity, a red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapeutic and aiming beams are guided down an optical fibre delivery system to a focusing handpiece. The laser is used in a non-contact mode.
The DEPILASE TWIN YAG Laser System is designed with 5 major sub-systems:
- a) A high voltage power supply which converts and rectifies the a.c. mains current to provide regulated power for the flashlamp simmer current and main triggering pulse.
- b) A cooling system consisting of an internal water flow circuit together with water to air heat exchanger.
- c) An Nd: YAG laser rod, capable of generating optical pulses at a frequency up to 3 Hz
- d) An optical delivery system, interfacing the energy from the laser to the patient via an optical fibre and focusing handpiece.
- e) The microprocessor based controller which regulates the functions of the laser and allows parameter selection by the user.
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.
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
MAY 1 4 2003
K0 30510
1 ஆ 2
Appendix E
510 (k) Summary
-
- General Information:
| Company: | Depilase Group Ltd
One Canada Square
Canary Wharf
London E14 5DY
United Kingdom |
|--------------------|---------------------------------------------------------------------------------------------|
| Contact Person: | Dr. Mario Luca Russo |
| Preparation: | 11-15-02 |
| Device Trade Name: | DEPILASE TWIN YAG Laser System |
| Common Name: | Long Pulsed Nd:YAG Surgical, Powered, Lase
79-GEX
21 CFR 878-48 |
I. Description
The DEPILASE TWIN YAG Laser System is based on Nd: YAG laser technology. Within the system, an optical cavity contains the Nd: YAG crystal, which is activated by means of the use of a flashlamp, with the option of frequency doubling the fundamental laser wavelength, from 1064 nm to 532 nm. The frequency doubling wavelength is obtained by passing with the laser radiation through a special crystal called Second Harmonic Crystal (SHC). After the cavity, a red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapeutic and aiming beams are guided down an optical fibre delivery system to a focusing handpiece. The laser is used in a non-contact mode.
The DEPILASE TWIN YAG Laser System is designed with 5 major sub-systems:
- a) A high voltage power supply which converts and rectifies the a.c. mains current to provide regulated power for the flashlamp simmer current and main triggering pulse.
- b) A cooling system consisting of an internal water flow circuit together with water to air heat exchanger.
- c) An Nd: YAG laser rod, capable of generating optical pulses at a frequency up to 3 Hz
- d) An optical delivery system, interfacing the energy from the laser to the patient via an optical fibre and focusing handpiece.
- e) The microprocessor based controller which regulates the functions of the laser and allows parameter selection by the user.
1
K0 30510 log 2
II. Intended Use
The DEPILASE TWIN YAG Laser System is indicated for the use in dermatological applications for the non invasive treatment of facial wrinkles ( 1064 nm laser emission).
III. Summary of Substantial Equivalence
Depilase believes that its DEPILASE TWIN YAG Laser System is substantially equivalent. regarding the 1064 nm laser emission , to the Laserscope Lyra (K020021) Nd: YAG laser. previously cleared for the use in dermatological applications for the non invasive treatment of facial wrinkles.
It therefore has the same Intended Use as the DEPILASE TWIN YAG Laser System.
Technologically, the predicate device has identical characteristics to the DEPILASE TWIN Y AG Laser System, comprising a flashlamp pumped Nd: Y AG laser rod generating light at a wavelength of 1064 nm, which is subsequently delivered to the patient via an optical fibre delivery system and focusing handpiece.
The DEPILASE TWIN YAG Laser System output characteristics are very similar to those of the predicate device.
All lasers are microprocessor controlled devices.
All lasers utilize Class I aiming beams which pose no hazard to the user.
All systems utilize an internal closed loop water-air heat exchange circuit for optimal thermal control of the laser cavity.
The risk and benefits of the DEPILASE TWIN YAG Laser System are comparable to the predicate device 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.
2
Image /page/2/Picture/1 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around the perimeter. In the center is a stylized image of an eagle with three lines representing its wings and body. The eagle faces to the right.
MAY 1 4 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Mario Luca Russo Director of Research and Development Depilase Group Ltd. One Canada Square Canary Wharf London E14 5DY United Kingdom
Re: K030510
Trade/Device Name: DEPILASE TWIN YAG Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: January 5, 2003 Received: February 19, 2003
Dear Dr. Russo:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Dr. Mario Luca Russo
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
APPENDIX F
INDICATIONS FOR USE STATEMENT
K030510 510 (K) Number (if known): _
Device Name:
DEPILASE TWIN YAG LASER SYSTEM
Indications For Use:
The DEPILASE TWIN YAG Laser System is intended for the coagulation and haemostasis of vascular lesions (1064 and 532 nm wavelengths), the removal and permanent reduction of unwanted hair in Fitzpatrick skin type I - VI and the dermatological use for the non invasive treatment of facial wrinkles (1064 nm wavelength).
(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 and Neurological Devices KO30510 510(k) Number Prescription Use OR Over The Counter Use (per 21 CFR 801.109)
Premarket Notification for DEPILASE TWIN YAG Laser System