(39 days)
No
The description focuses on the physical components and operation of a laser system, with a microprocessor controller for parameter selection, but no mention of AI or ML for data analysis, decision-making, or image processing.
Yes.
The device is intended for the coagulation and haemostasis of vascular lesions and the removal and permanent reduction of unwanted hair, indicating a therapeutic purpose.
No
The device is described as a laser system intended for "coagulation and haemostasis of vascular lesions" and "removal and permanent reduction of unwanted hair". These are therapeutic and aesthetic purposes, not diagnostic ones.
No
The device description clearly outlines multiple hardware components including a laser rod, optical delivery system, power supply, and cooling system, indicating it is a hardware-based medical device with a software controller.
Based on the provided information, the DEPILASE TWIN YAG Laser System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the device is for the coagulation and haemostasis of vascular lesions and the removal and permanent reduction of unwanted hair. These are therapeutic and aesthetic procedures performed directly on the patient's body.
- Device Description: The description details a laser system that delivers energy to the patient via an optical fibre and handpiece. This is consistent with a device used for external treatment.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or the handling of biological specimens.
Therefore, the DEPILASE TWIN YAG Laser System is a therapeutic/aesthetic medical device, not an IVD.
N/A
Intended Use / Indications for Use
The DEPILASE TWIN YAG Laser System is indicated for the coagulation and haemostasis of vascular lesions and/or the removal and permanent reduction of unwanted hair in Fitzpatrick skin types I - VI, including suntanned skin types.
The DEPILASE TWIN YAG Laser System is intended for the coagulation and haemostasis of vascular lesions( 1064 and 532 nm wavelengths) and the removal and permanent reduction of unwanted hair in Fitzpatrick skin types I -VI, including suntanned skin types (1064 nm wavelength).
Product codes
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 warelonging 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 (SHO). 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)
Reference Device(s)
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
K020697 //
Appendix E
510 (k) Summary
APR 1 2 2002
- General Information: 1.
・・
| Company: | Depilase Group Ltd
One Canada Square
Canary Wharf
London E14 5DY
United Kingdom |
|--------------------|---------------------------------------------------------------------------------------------|
| Contact Person: | Dr. Mario Luca Russo |
| Preparation: | 12-01-01 |
| Device Trade Name: | DEPILASE TWIN YAG Laser System |
| Common Name: | Long Pulsed Nd:YAG Surgical, Powered, Laser
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 warelonging 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 (SHO). 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
The DEPILASE TWIN YAG Laser System is indicated for the coagulation and haemostasis of vascular lesions and/or the removal and permanent reduction of unwanted hair in Fitzpatrick skin types I - VI, including suntanned skin types.
III. Summary of Substantial Equivalence
Depilase believes that its DEPILASE TWIN YAG Laser System is substantially equivalent, Doprade Done res that laser emission , to the Laserscope Lyra (K990718) and Altus Medical Aesthetic CoolGlide (K991798) Nd: YAG lasers, previously cleared for both the coagulation and haemostasis of vascular lesions and/or the removal and permanent reduction of unwanted hair in Fitzpatrick skin types I - VI, including suntanned skin types, and regarding the 532 nm laser President to the Fotona Dualis KTP ( K011939) previously cleared for the coagulation and haemostasis of vascular lesions
They therefore have the same Intended Use as the DEPILASE TWIN YAG Laser System.
Technologically, the predicate devices have identical characteristics to the DEPILASE TWIN YAG Laser System, all comprising a flashlamp pumped Nd: YAG laser rod generating light at a wavelength of 1064nm or 532 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 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 TWIN YAG 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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, representing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 2 2002
Depilase Group Ltd. c/o Ms. Pamela Gwynn Engineering Team Leader Underwriters Laboratories, Inc. 12 Laboratory Drive Research Triangle Park, NC 27709-3995
Re: K020697
Trade/Device Name: Depilase Twin YAG Laser System Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: March 21, 2002 Received: March 28, 2002
Dear Ms. Gwynn:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your because be device is substantially equivalent (for the indications ferenced above and have sure) to legally marketed predicate devices marketed in interstate for use stated in the exciesems 776, the enactment date of the Medical Device Amendments, or to conninered processified in accordance with the provisions of the Federal Food, Drug, de vices that have boon require approval of a premarket approval application (PMA). and Cosmetic (110. (110.) that to nevice, subject to the general controls provisions of the Act. The r ou may, mererere, mains 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 If your device is exassinos (tional controls. Existing major regulations affecting your device can may or subject to basil as a substions, 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 r lease of acribed that I branination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I edelar statutes and sequirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of A rate 677) its ensight (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 – Ms. Pamela Gwynn
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 and additionally 21 CFR Part 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 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). 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,
Muriam C. Provost
Cor 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
510 (K) Number (if known): _ k 020697
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) and the removal and permanent reduction of unwanted hair in Fitzpatrick skin types I -VI, including suntanned skin types (1064 nm wavelength).
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C Provost
(Division Sign-Off)
Division of General, Restorative and Neurological Devices
| Prescription Use | ✓ |
|---|---|
| (per 21 CFR 801.109) |
| 510(k) Number | K020697 |
|---|---|
| OR | Over The Counter Use ______ |
Premarket Notification for DEPILASE TWIN YAG Laser System