(15 days)
Not Found
No
The description focuses on laser technology and its operating modes, with no mention of AI or ML.
Yes
The device is described as aiding in the "removal of tattoos and treatment of benign pigmented lesions," and "removal of unwanted hair," which are therapeutic applications.
No
The device description and intended uses clearly state the device (SINON laser system) is used for therapeutic purposes like cutting, vaporization, ablation of soft tissue, tattoo removal, treatment of pigmented lesions, and hair removal. It does not mention any diagnostic functions such as detection, diagnosis, or monitoring of diseases or conditions.
No
The device description explicitly states it is a "694 nm Ruby laser system," which is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses described are for the cutting, vaporization, or ablation of soft tissue, removal of tattoos, treatment of benign pigmented lesions, and removal of unwanted hair. These are all therapeutic or surgical procedures performed directly on the patient's body.
- Device Description: The device is a laser system designed to deliver energy to tissue. This aligns with therapeutic or surgical devices, not devices used to examine specimens in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue samples, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to directly interact with and modify tissue on the patient.
N/A
Intended Use / Indications for Use
The SINON is indicated:
- In the Q-Switch Mode, for the cutting, vaporization, or ablation of soft tissue. This includes the removal of tattoos and treatment of benign pigmented lesions.
- In the Free-Running Mode, for the removal of unwanted hair in patients with Fitzpatrick skin types of I and II.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The SINON is a 694 nm Ruby laser system which can be operated in two different modes. The quality-switch or Q-switch or QS Operating Mode is characterized by extremely short pulse widths (ns = 10 °s) and high peak power (MW = 106 W). The QS Operating Mode in the SINON is used for the removal of tattoos and treatment of pigmented lesions. The second mode is the Free-Running Operating Mode which is used for the removal of hair.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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)
None presented.
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.
K040433, K991285, K910422, K9909002, K971814, K040384
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
Image /page/0/Picture/1 description: The image shows the text "K 050218" above the WaveLight logo. The WaveLight logo consists of three horizontal wavy lines stacked on top of each other, followed by the word "WaveLight" in a sans-serif font. A registered trademark symbol is present to the right of the word "WaveLight".
510(k) Summary of Safety and Effectiveness
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
1. General Information
| Submitter: | WaveLight Laser Technologie, AG
Am Wolfsmantel 5
91058 Erlangen
Germany |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Alexander Popp
Am Wolfsmantel 5
91058 Erlangen
Germany
Telephone: +49 (0)9131-6186-121
Fax: +49 (0)9131-6186-202 |
| Summary Preparation Date: | December 16, 2004 |
| 2. Names | |
| Device Name: | SINON |
| Classification Name: | Laser Instrument, Surgical Powered
Product Code: GEX
Panel: Dermatology and Plastic Surgery |
3. Predicate Devices
This submission refers to the SINON device registered under 510(k) number K040433. Therefore the SINON described here is substantially equivalent to the SINON registered under 510(k) number K040433.
The SINON laser system is furthermore substantially equivalent to the Aesculap-Meditec RubyStar Laser System with Normal and Q-Switch Mode (K991285), the Spectrum Medical Technologies RD-1200 (K910422), the MLT Laser Technologies Inc. MLT R694 (K9909002), the Mehl/Biophile Inc. Chromos 694 (K971814) and WaveLights SINON device (K040384).
1
510(k) Summary of Safety and Effectiveness
4. Device Description
The SINON is a 694 nm Ruby laser system which can be operated in two different modes. The quality-switch or Q-switch or QS Operating Mode is characterized by extremely short pulse widths (ns = 10 °s) and high peak power (MW = 106 W). The QS Operating Mode in the SINON is used for the removal of tattoos and treatment of pigmented lesions. The second mode is the Free-Running Operating Mode which is used for the removal of hair.
5. Indications for Use
The SINON is indicated:
-
- In the Q-Switch Mode, for the cutting, vaporization, or ablation of soft tissue. This includes the removal of tattoos and treatment of benign pigmented lesions.
-
- In the Free-Running Mode, for the removal of unwanted hair in patients with Fitzpatrick skin types of I and II.
-
- Performance Data
None presented.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 5 2005
Wavelight Laser Technologie AG c/o Mr. Morten S. Christensen Underwriters Laboratories, Inc. 1655 Scott Boulevard Santa Clara, California 95050
Re: K050218 Trade/Device Name: SINON 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 25, 2005 Received: January 31, 2005
Dear Mr. Christensen:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 310(tr) prematice is substantially equivalent (for the indications referenced above and nave uctoringed in active acted predicate devices marketed in interstate for use stated in the cherosule) to regars mannet date of the Medical Device Amendments, or to commerce prior to May 20, 1976, the enations with the provisions of the Federal Food. Drug. devices that have been reclassified in accessful of a premarket approval application (PMA). and Cosment Act (Act) market the device, subject to the general controls provisions of the Act. The You may, merclore, manel the act include requirements for annual registration, listing of general controls provisions of the rice, 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 classified (soc aborto) ins existing major regulations affecting your device can may be subject to such additional controlier is more of Parts 800 to 898. In addition, FDA may be found in the Ood of Peaces one ming your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuated of a baces in other requirements of the Act
that FDA has made a determination that your device complies with other requirements of the A that FDA has made a decemmation and your are your are Federal agencies. You must or any Federal statutes and regarations and limited to: registration and listing (21 comply with an the Act 3 requirements, n.c., good manufacturing practice requirements as set CFR Part 807), adoling (21 OFRT art 820); and if applicable, the electronic forin in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Mr. Morten S. Christensen
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter whi anow you to begin matteeing your antial equivalence of your device to a legally premarket nothleation: The PDA maing of basification 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 If you desire specific advice for your do 11 - 11 - 11 5. Also, please note the regulation entitled, Colliation of Compulance and (21 the Part 807.97). You may obtain Misoranting of Telefonoe to prementovnibilities under the Act from the Division of Small other general information on your respended its toll-free number (800) 638-2041 or Manufacturers, Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Wilkerson
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
ど WaveLight®
20
510 (k) Indication for Use
| 510(k) Number (if known): | K050218 | Indications for Use |
|---|---|---|
| Device Name: | SINON |
Indications for Use:
-
- In the Q-Switch Mode, for the cutting, vaporization, or ablation of soft tissue. This includes the removal of tattoos and treatment of benign pigmented lesions.
-
- In the Free-Running Mode, for the removal of unwanted hair in patients with Fitzpatrick skin types of I and II.
| Prescription Use (Part 21 CFR 801 Subpart D) | X |
|---|---|
| AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
for Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
| Page | 1 of 1 |
|---|---|
| (indication for use only) |
| 510(k) Number | K050218 |
|---|---|
| --------------- | --------- |