(53 days)
No
The document describes a laser system with specific wavelengths and delivery methods, focusing on its physical components and intended dermatological applications. There is no mention of AI, ML, image processing, or any data-driven decision-making processes within the device description or performance studies.
Yes
The device is intended for the "treatment of" various conditions such as vascular lesions, pigmented lesions, cutaneous lesions, and acne vulgaris, which aligns with the definition of a therapeutic device.
No
The VariLite Laser System is described as a treatment device, used to deliver laser light for various dermatological applications like treating vascular lesions, pigmented lesions, and cutaneous lesions. It does not mention any diagnostic capabilities.
No
The device description explicitly states that the VariLite is a "dual wavelength medical diode laser source" with physical components like a "laser console, footswitch, and a variety of fiber optic handpiece delivery devices." This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, the VariLite Laser System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "dermatological applications" and lists various skin conditions and hair removal as its indications. This involves direct treatment of the patient's body.
- Device Description: The description details a laser system with handpieces and a scanner, designed to deliver laser light to the skin.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the human body. The VariLite Laser System is a therapeutic device used to treat conditions directly on the patient's skin.
N/A
Intended Use / Indications for Use
The VariLite is intended for use in dermatological applications: The 532 nm wavelength delivered with VariLite handpieces, DioLite 532 handpieces, and the ScanLite Scanner is indicated for:
- the treatment of vascular lesions including: .
- Telangiectasia Cherry Angiomas - -Leg Veins Neovascularization - -Spider Angiomas Port Wine Stains -ﺳ -Roscea -Venous Lakes the treatment of benign pigmented lesions including: . Lentigines Freckles --Dermatosis Papulosis Nigra Poikloderma of Civatte -- Café- au- lait Stains -Melasma the treatment of cutaneous lesions including: . Verruca Keratoses ー -
- Skin Tags -
.
.
-
the treatment of moderate inflammatory acne vulgaris. .
The 940 nm wavelength delivered with VariLite handpieces is indicated for: -
the treatment of vascular lesions including: Telangiectasia Cherry Angiomas --Leg Veins ﯩ Neovascularization -Spider Angiomas -Port Wine Stains -Roscea Venous Lakes ・ the treatment of benign pigmented lesions including: Lentigines --Freckles Dermatosis Papulosis Nigra Poikloderma of Civatte ---Café- au- lait Stains -Melasma
-
hair removal .
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The VariLite is a dual wavelength medical diode laser source that delivers laser light at either 532 nm or 940 nm. Its main components are a laser console, footswitch, and a variety of fiber optic handpiece delivery devices, including manual handpieces and the ScanLite Scanner, which are all considered part of the VariLite Laser System. The VariLite console is also intended to be compatible with other delivery devices that have been the subject of previous 510(k) applications. These devices include DioLite 532 handpieces (K964074).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
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)
Non-Clinical performance Data: Non-clinical performance testing to applicable consensus and voluntary standards is demonstrated via a Declaration of Conformity.
Clinical performance Data: None
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.
K964074, K951034, K024206, K973828, K003993
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
04 1930 1/3
510(k) Summary IRIDEX Corporation VariLite Laser System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
John Jossy IRIDEX Corporation 1212 Terra Bella Avenue Mountain View, CA 94043 (650) 962-8848 ext. 3016
SEP 1 0 2004
Contact Person: (same as above)
Date Prepared: May 27, 2004
Name of Device and Name/Address of Sponsor
VariLite Laser System
IRIDEX Corporation 1212 Terra Bella Avenue Mountain View, CA 94043
Classification Name
Laser Instrument, Surgical, Powered CFR Section: 878.4810 Product Code: GEX
Predicate Devices
The VariLite Laser System (VariLitc) is substantially equivalent to other currently legally marketed dermatology laser devices including those in the following table:
| Name | Manufacturer | 510(k) # |
|---|---|---|
| DioLite 532 | IRIDEX Corporation | K964074 |
| Aura | Laserscope | K951034 /K024206 |
| Prima KTP | Nidek, Inc. | K973828 |
| Medilas D SkinPulse S | Dornier MedTech | K003993 |
1
K041930 2/3
Device Description
The VariLite is a dual wavelength medical diode laser source that delivers laser light at either 532 nm or 940 nm. Its main components are a laser console, footswitch, and a variety of fiber optic handpiece delivery devices, including manual handpieces and the ScanLite Scanner, which are all considered part of the VariLite Laser System. The VariLite console is also intended to be compatible with other delivery devices that have been the subject of previous 510(k) applications. These devices include DioLite 532 handpieces (K964074).
Intended Use/Indications for Use
The VariLite is intended for use in dermatological applications: The 532 nm wavelength delivered with VariLite handpieces, DioLite 532 handpieces, and the ScanLite Scanner is indicated for:
- the treatment of vascular lesions including: .
- Telangiectasia Cherry Angiomas - -Leg Veins Neovascularization - -Spider Angiomas Port Wine Stains -ﺳ -Roscea -Venous Lakes the treatment of benign pigmented lesions including: . Lentigines Freckles --Dermatosis Papulosis Nigra Poikloderma of Civatte -- Café- au- lait Stains -Melasma the treatment of cutaneous lesions including: . Verruca Keratoses ー -
- Skin Tags -
.
.
-
the treatment of moderate inflammatory acne vulgaris. .
The 940 nm wavelength delivered with VariLite handpieces is indicated for: -
the treatment of vascular lesions including: Telangiectasia Cherry Angiomas --Leg Veins ﯩ Neovascularization -Spider Angiomas -Port Wine Stains -Roscea Venous Lakes ・ the treatment of benign pigmented lesions including: Lentigines --Freckles Dermatosis Papulosis Nigra Poikloderma of Civatte ---Café- au- lait Stains -Melasma
-
hair removal .
Technological Characteristics and Substantial Equivalence
The VariLite is a dual wavelength diode laser which delivers laser light at the wavelengths of 532 nm and 940 nm.
2
K041930 3/3
The IRIDEX Corporation DioLite 532 delivers a wavelength of 532 nm and is indicated for the treatment of vascular and pigmented lesions. Thus, it delivers the same wavelength and has similar indications to those of the VariLite.
The Laserscope Aura delivers laser light at a wavelength of 532 nm and is indicated for the treatment of vascular and pigmented lesions; for the treatment of cutaneous lesions: and for the treatment of acne vulgaris. Thus, it delivers the same wavelength and has similar indications to those of the VariLite.
The Nidek. Inc Prima KTP delivers laser light at a wavelength 532 nm and is indicated for the treatment of vascular and pigmented lesions and the treatment cutaneous lesions. Thus it delivers the same wavelength and has similar indications to those of the VariLite.
The Dornier MedTcch Medilas D SkinPulse S delivers laser light at a wavelength of 940 nm. It is indicated for the treatment of vascular and pigmented skin lesions and for hair removal. Thus it delivers the same infrared wavelength and has similar indications to those of the VariLite.
Non-Clinical performance Data
Non-clinical performance testing to applicable consensus and voluntary standards is demonstrated via a Declaration of Conformity.
Clinical performance Data
Nonc
Conclusion
The VariLite is substantially equivalent to predicate devices currently legally marketed for the intended use/indications for use above.
3
Image /page/3/Picture/2 description: The image is a black and white emblem for the U.S. Department of Health & Human Services. The emblem features a stylized eagle with three stripes forming its body and wings. The eagle is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 0 2004
Iridex Corporation c/o Mr. Daniel W. Lehtonen Staff Engineer – Medical Devices Intertek Testing Services NA, Inc. 70 Codman Hill Road Boxborough, Massachusetts 01719
Re: K041930
Trade/Device Name: VariLite 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: August 26, 2004 Received: August 27, 2004
Dear Mr. Lehtonen:
We have reviewed your Section 510(k) premarket notification of intent to market the device w o nave rowled your your we determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the encreations of the enactment date of the Medical Device Amendments, or to conimered pror to ria) 2011-07-12, 2017 11:25 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 r ou may aller 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 or any i 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.
4
Page 2 - Mr. Daniel W. Lehtonen
This letter will allow you to begin marketing your device as described in your Section 510(k) I mo letter with and on. The FDA finding of substantial equivalence of your device to a legally premantee nevice 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 it four attails office of Compliance at (301) 594-4659. 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 from the Division of Small Marc Sacturers, 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
C.S. - M.S. - Ph.D.
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
5
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K041930
Device Name: IRIDEX VarilLite Laser System____________________________________________________________________________________________________________________________________
Indications For Use:
.
The VariLite Laser System is intended for use in dermatological applications:
The 532 nm wavelength delivered with VariLite handpieces, DioLite 532 handpieces, and the ScanLite Scanner is indicated for:
- the treatment of vascular lesions including: ●
- Cherry Angiomas -Telangiectasia -
- Neovascularization ﮯ Leg Veins
- Port Wine Stains -
- Spider Angiomas Venous Lakes -
- Neovascularization ﮯ Leg Veins
- Cherry Angiomas -Telangiectasia -
- Roscea ー the treatment of benign pigmented lesions including: .
- Freckles Lentigines --
- Poikloderma of Civatte Dennatosis Papulosis Nigra
- -Melasma Café- au- lait Stains ﺘ
- Freckles Lentigines --
- the treatment of cutaneous lesions including: .
- Keratoses -Verruca -
- Skin Tags -
- the treatment of moderate inflammatory acne vulgaris. .
The 940 nm wavelength delivered with VariLite handpieces is indicated for:
- the treatment of vascular lesions including: .
- Cherry Angiomas Telangiectasia -.
- Neovascularization Leg Veins t
- Port Wine Stains Spider Angiomas
- -Roscea ・
- Cherry Angiomas Telangiectasia -.
- the treatment of benign pigmented lesions including: .
- Lentigines -
- Dermatosis Papulosis Nigra -
- Café- au- lait Stains -
- hair removal .
Prescription Use _____________________________________________________________________________________________________________________________________________________________
OR (Per 21 CFR 801.109)
Over-The-Counter Use - - -
luation (ODE)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Venous Lakes
Poikloderma of Civatte
Freckles
Melasma
Concurrent
(Division Sign-Out)
Division of General, Restorative. and Neurological Devices
510(k) Number Kot/ 930