(26 days)
No
The summary describes a laser device controlled by computer software, but there is no mention of AI or ML capabilities, image processing, or data sets typically associated with AI/ML training or testing.
Yes
The device is described as treating various medical conditions and cosmetic issues, such as vascular lesions, warts, scars, psoriasis, wrinkles, and acne, which are all therapeutic in nature.
No
The device is described as a laser system intended for therapeutic purposes like coagulation, hemostasis, treatment of lesions, wrinkles, and hair removal. There is no mention of its use for diagnosis or detection of diseases or conditions.
No
The device description clearly outlines multiple hardware components including a laser console, optical delivery system, hand set, and foot switch. While it mentions being controlled by computer software, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the SKIN CLEAR SRVH Long Pulsed Nd:YAG Laser delivers laser energy directly to the treatment site on the patient's skin. The intended uses are all related to treating various skin conditions and removing hair through direct application of laser energy.
- Lack of Sample Analysis: There is no mention of collecting samples from the patient or performing any analysis on those samples.
The device is a therapeutic laser intended for direct application to the body for treatment purposes, not for diagnostic testing using in vitro samples.
N/A
Intended Use / Indications for Use
1064 nm: Intended for the coagulation and hemostasis of benign vascular lesions, such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and the treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis. The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos, solar lentigos, Café au lait macules, seborrheic keratoses, nevi, chloasma, verrucea, skin tags, keratoses, and plaques.
The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. Additionally, the laser is indicated for the removal of unwanted hair, for the stable long-term, or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment of pseudofolliculitis barbae. Indicated for use on all skin types (Fitzpatrick I-IV), including tanned skin.
1320 nm: For use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue. For use in the treatment of fine lines and wrinkles. It is also indicated for the treatment of back acne and atrophic acne scars.
Product codes
GEX
Device Description
The SKIN CLEAR SRVH Long Pulsed Nd:YAG Laser is a compact self-contained device that delivers a beam of laser energy at infrared wavelengths of 1064 nm and 1320 nm to the treatment site. The SKIN CLEAR SRVH Long Pulsed Nd: YAG Laser consists of six (6) primary components:
-
- Laser console;
-
- Internal computer;
- Control panel and display;
- Optical delivery system;
- Hand set with integrated cooling (chilled sapphire optical window);
- Foot switch
The SKIN CLEAR SRVH Long Pulsed Nd: YAG Laser is not battery operated, but is controlled and operated with the aid of computer software.
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
Nonclinical Performance Data: None
Clinical Performance Data: None
Key Metrics
Not Found
Predicate Device(s)
K032459, K043046, K023954, K011828, K070388, K033172
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
APR - 7 2008
510(k) Summary
AMJET Distribution, LLC SKIN CLEAR SRVH Long Pulsed Nd:YAG Laser 510(k) Premarket Notification
| Submitter: | Global USA Distribution, LLC |
|---|---|
| Address: | 10723 Aquila Av. S. |
| Contact Person: | Ronald E. Berglund |
| Telephone: | 952-220-3014 |
| Facsimile: | 952-888-8887 |
| Date Prepared: | August 31, 2007 |
| Device Trade Name: | SKIN CLEAR SRVH Long Pulsed Nd:YAG Laser |
| Classification Name: | Instrument, Powered, Laser |
| 79-GEX 21 CFR 878.4810 | |
| Legally Marketed Predicate | |
| Devices: | Sciton Profile ThermaScan (K032459), |
| CoolTouch CT3S Nd: YAG Laser System | |
| (K043046), Cutera CoolGlide CV Laser | |
| (K023954), Cynosure Acclaim Dermatology | |
| Laser (K011828), Sciton Profile Multi-Platform | |
| System (K070388), Candela GentleYag | |
| (K033172) |
1
Description of the Long-Pulse Nd: Y AG Laser:
The SKIN CLEAR SRVH Long Pulsed Nd:YAG Laser is a compact self-contained device that delivers a beam of laser energy at infrared wavelengths of 1064 nm and 1320 nm to the treatment site. The SKIN CLEAR SRVH Long Pulsed Nd: YAG Laser consists of six (6) primary components:
-
- Laser console;
-
- Internal computer;
-
Control panel and display;
-
Optical delivery system;
-
Hand set with integrated cooling (chilled sapphire optical window);
-
Foot switch
The SKIN CLEAR SRVH Long Pulsed Nd: YAG Laser is not battery operated, but is controlled and operated with the aid of computer software.
Intended Use of the Long-Pulse Nd: Y AG Laser:
1064 nm: Intended for the coagulation and hemostasis of benign vascular lesions, such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and the treatment of benign cutaneous lesions such as warts. scars, striae and psoriasis. The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos, solar lentigos, Café au lait macules, seborrheic keratoses, nevi. chloasma, verrucea, skin tags, keratoses, and plaques.
The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. Additionally, the laser is indicated for the removal of unwanted hair, for the stable long-term, or permanent, hair reduction through selective targeting of merlanin in hair follicles, and for the treatment of pseudofolliculitis
2
| | barbae. Indicated for use on all skin types
(Fitzpatrick I-IV), including tanned skin. |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 1320 nm: For use in dermatology for incision,
excision, ablation and vaporization with hemostasis
of soft tissue. For use in the treatment of fine lines
and wrinkles. It is also indicated for the treatment of
back acne and atrophic acne scars. |
| Nonclinical Performance
Data: | None |
| Clinical Performance
Data: | None |
| Additional Information | None requested at this time |
| Conclusion: | The SKIN CLEAR SRVH Long Pulsed Nd:YAG
Laser shares the same indications for use, similar
design features (including wavelengths, laser
medium, power supply, cooling and control
systems), functional features (including power
output, repetition rate, energy, spot sizes and energy
fluence), and is therefore substantially equivalent to
the above legally marketed laser systems currently
in commercial distribution. |
:
3
Image /page/3/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 is a staff with two snakes coiled around it. The caduceus is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the left side of the image. The text is in all capital letters.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 7 2008
Global USA Distribution, LLC % Underwriters Laboratories, Inc. Mr. Ned Devine Sr. Staff Engineer 333 Pfingsten Road Northbrook, Illinois 60062
Re: K080697
Trade/Device Name: SKIN CLEAR SRVH Long Pulsed Nd: YAG Laser 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: March 31, 2008 Received: April 1, 2008
Dear Mr. Devine:
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
4
Page 2 – Mr. Ned Devine
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.
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Mullison
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): _ KO80697
Device Name: SKIN CLEAR SRVH Long Pulsed Nd:YAG Laser
Indications for Use:
1064 nm: Intended for the coagulation and hemostasis of benign vascular lesions, such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and the treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis. The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos, solar lentigos, Café au lait macules, seborrheic keratoses, nevi, chloasma, verrucea, skin tags, keratoses, and plaques.
The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. Additionally, the laser is indicated for the removal of unwanted hair, for the stable long-term, or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment of pseudofolliculitis barbae. Indicated for use on all skin types (Fitzpatrick I-IV), including tanned skin.
1320 nm: For use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue. For use in the treatment of fine lines and wrinkles. It is also indicated for the treatment of back acne and atrophic acne scars.
| Prescription Use: X AND/OR Over-The-Counter Use |
|---|
| (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) |
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neat R.P. Oyler for mkm
sion Sign Off
Division Sign-Off) Division of General. Restorative, and Neurological Devices
510(k) Number_KO80697