(90 days)
Not Found
No
The device description details a laser system with a microprocessor-based controller for parameter selection, but there is no mention of AI or ML capabilities for image processing, data analysis, or automated decision-making.
Yes.
The device is intended for medical applications such as the coagulation and haemostasis of vascular lesions and the non-invasive treatment of facial wrinkles.
No
The device description and intended use outline therapeutic and aesthetic applications (coagulation, hair removal, wrinkle treatment) rather than diagnostic functions.
No
The device description clearly outlines multiple hardware components including laser rods, power supply, cooling system, optical delivery systems, and a handpiece, indicating it is a physical medical device, not software-only.
Based on the provided information, the DEPILASE TRIO LASE Laser System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes procedures performed directly on the patient's body (coagulation and haemostasis of vascular lesions, hair removal, treatment of facial wrinkles). IVD devices are used to examine specimens taken from the body (like blood, urine, tissue samples) to provide information about a person's health.
- Device Description: The description details a laser system that delivers energy to the patient's skin via a handpiece in a non-contact mode. This is consistent with a therapeutic or aesthetic device used on the body, not a device for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, reagents, or any processes related to in vitro testing.
Therefore, the DEPILASE TRIO LASE Laser System is a medical device used for direct treatment on the patient, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The DEPILASE TRIO LASE Laser System is intended for the coagulation and haemostasis of vascular lesions ( 532 and 1064 nm ), the removal and permanent reduction of unwanted hair in Fitzpatrick skin types I -VI, including suntanned skin types (755 and 1064 nm) and the dermatological applications for the non invasive treatment of facial wrinkles (1064 nm).
Product codes
GEX
Device Description
The DEPILASE TRIO LASE Laser System is based on Nd: YAG and Alexandrite Jaser technology. Within the same system, one optical cavity contains the Nd: YAG crystal, and another optical cavity contains the Alexandrite crystal, which are activated by means of the use of a flashlamp. After each 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 individual optical fibre delivery system to a focusing handpiece. The laser is used in a noncontact mode.
The DEPILASE TRIO LASE Laser System is designed with 6 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 2 Hz.
- d) An Alexandrite laser rod, capable of generating optical pulses at a frequency up to 2 Hz.
- e) Two optical delivery systems, interfacing the energy from each laser cavity to the patient via an indipendent optical fibre and focusing handpiece.
- The microprocessor based controller which regulates the functions of the laser and allows f) 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
Not Found
Key Metrics
Not Found
Predicate Device(s)
K990718, K020021, K991798, K011939, K994260, K984601, K992757
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
Appendix E
:
510 (k) Summary
MAY 2 0 2003
- 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 TRIO LASE Laser System |
| Common Name: | Long Pulsed Nd:YAG and Alexandrite Surgical, Powered, Laser
79—GEX
21 CFR 878-48 |
I. Description
The DEPILASE TRIO LASE Laser System is based on Nd: YAG and Alexandrite Jaser technology. Within the same system, one optical cavity contains the Nd: YAG crystal, and another optical cavity contains the Alexandrite crystal, which are activated by means of the use of a flashlamp. After each 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 individual optical fibre delivery system to a focusing handpiece. The laser is used in a noncontact mode.
The DEPILASE TRIO LASE Laser System is designed with 6 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 2 Hz.
- d) An Alexandrite laser rod, capable of generating optical pulses at a frequency up to 2 Hz.
- e) Two optical delivery systems, interfacing the energy from each laser cavity to the patient via an indipendent optical fibre and focusing handpiece.
- The microprocessor based controller which regulates the functions of the laser and allows f) parameter selection by the user.
Premarket Notification for DEPILASE TRIO LASE Laser System
1
The DEPILASE TRIO LASE Laser System is indicated for the coagulation and haemostasis of vascular lesions, the removal and permanent reduction of unwanted hair in Fitzpatrick skin types I - VI, including suntanned skin and the dermatological applications for the non invasive treatment of facial wrinkles
III. Summary of Substantial Equivalence
Depilase believes that its DEPILASE TRIO LASE Laser System is substantially equivalent, regarding the Nd:YAG laser emission, to the Laserscope Lyra (K990718. K020021), and Altus Medical Aesthetic CoolGlide (K991798) Nd: YAG Lasers previously cleared for both the coagulation and hemostasis of vascular lesions, the removal and permanent reduction of unwanted hair in Fitzpatrick skin types I - VI, including suntanned skin types and the non invasive treatment of wrinkles, regarding the 532 nm laser emission to the Fotona Dualis KTP (K011939), previously cleared for the coagulation and haemostasis of vascular lesions and regarding the Alexandrite laser emission, to the Candela GenteLASE GL (K994260). GenteLASE II (K984601) and the Cynosure Apogee TSK (K992757) Alexandrite lasers, all previously cleared for the removal of unwanted hair in Fitzpatrick skin types I - IV
They therefore have the same Intended Use as the DEPILASE TRIO LASE Laser System.
Technologically, the predicate devices have identical characteristics to the DEPILASE TRIO LASE Laser System, all comprising a flashlamp pumped Nd: YAG laser rod generating light at a wavelength of 1064 nm or 532nm, or a flashlamp pumped Alexandrite laser rod generating light at a wavelength of 755 nm which is subsequently delivered to the patient via an individual optical fibre delivery system and focusing handpiece.
The DEPILASE TRIO LASE Laser System output characteristics are very similar to those of the predicate devices.
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 TRIO LASE Laser System are comparable to the predicate devices 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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, overlaid on three human profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
MAY 2 0 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 UK
Re: K030508
Trade/Device Name: Depilase Trio Lase 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.
3
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,
sincerely yours,
Mark A. Mikkelsen
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
INDICATIONS FOR USE STATEMENT
510 (K) Number (if known):
510 (K) Number (if known): ___________________________________________________________________________________________________________________________________________________
Device Name:
DEPILASE TRIO LASE LASER SYSTEM
Indications For Use:
The DEPILASE TRIO LASE Laser System is intended for the coagulation and haemostasis of vascular lesions ( 532 and 1064 nm ), the removal and permanent reduction of unwanted hair in Fitzpatrick skin types I -VI, including suntanned skin types (755 and 1064 nm) and the dermatological applications for the non invasive treatment of facial wrinkles (1064 nm).
(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 Sign-Off) | ||||
|---|---|---|---|---|---|
| (Division Sign-Off) |
Division of General, Restorative and Neurological Devices
| 510(k) Number: | K030508 |
|---|---|
| ---------------- | --------- |
| Prescription Use
| (per 21 CFR 801.109) | OR | Over The Counter Use |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |
Premarket Notification for DEPILASE TRIO LASE Laser System