the treatment of vascular lesions including:
- Telangiectasia
- Cherry Angiomas
- Leg Veins
- 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
the treatment of cutaneous lesions including:
- Verruca
- Keratoses
- 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
- 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.

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).

AI/ML Overview

The provided text is a 510(k) summary for the IRIDEX VariLite Laser System, which is a premarket notification for a medical device in the United States. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving clinical effectiveness through extensive clinical trials with acceptance criteria and statistical analyses.

Therefore, many of the requested elements for acceptance criteria and study design are not applicable in this context. The document explicitly states "Clinical performance Data: None."

Here's a breakdown of the information as it relates to your request:

1. A table of acceptance criteria and the reported device performance

Not Applicable. The 510(k) summary does not define specific clinical acceptance criteria or report a "performance" in the way a clinical trial would (e.g., sensitivity, specificity, accuracy). The submission relies on demonstrating substantial equivalence to existing predicate devices, meaning it has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. Performance is inferred from the safety and effectiveness profile of the predicate devices.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not Applicable. No clinical "test set" of patients was used as part of this 510(k) submission. Non-clinical performance data relied on "applicable consensus and voluntary standards" (e.g., electrical safety, electromagnetic compatibility), as indicated by a Declaration of Conformity.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. No clinical test set requiring ground truth establishment by experts was part of this submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not Applicable. No clinical test set was used.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This is a laser system for dermatological treatment, not an AI-assisted diagnostic or interpretative device. Therefore, MRMC studies and AI-related effectiveness are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a hardware device (laser system), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable. No clinical ground truth was established for this submission. The "ground truth" for showing substantial equivalence essentially lies in the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

Not Applicable. There is no "training set" in the context of this device. The device is not learning from data in the way an AI or diagnostic algorithm would.

9. How the ground truth for the training set was established

Not Applicable. See point 8.

Summary of Device Acceptance (as per 510(k) process):

The VariLite Laser System was accepted by the FDA based on a demonstration of substantial equivalence to existing, legally marketed predicate devices. This means the FDA concluded that the device is as safe and effective as the predicate devices, has the same intended use, and generally the same technological characteristics.

The "study" or evidence provided to meet this "acceptance criteria" (substantial equivalence) consists of:

Predicate Device Comparison: Detailed comparison of the VariLite Laser System's intended use, indications for use, and technological characteristics (wavelengths, delivery methods) to four predicate devices:
- IRIDEX Corporation DioLite 532 (K964074)
- Laserscope Aura (K951034 / K024206)
- Nidek, Inc. Prima KTP (K973828)
- Dornier MedTech Medilas D SkinPulse S (K003993)
Non-Clinical Performance Data: A "Declaration of Conformity" indicating that the device meets "applicable consensus and voluntary standards." This typically covers aspects like electrical safety, electromagnetic compatibility, and laser safety standards (e.g., IEC 60601-1, IEC 60825-1).
Absence of Clinical Data: Explicitly stated as "None," meaning no new clinical trials were conducted by the manufacturer for this specific 510(k) submission to demonstrate effectiveness or safety. The safety and effectiveness are inferred from the predicate devices.

The FDA's letter (K041930) confirms that the device was found "substantially equivalent" and thus permitted to market, based on the information provided in the 510(k) submission.

Summary

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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

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.

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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

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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 -
Roscea ー the treatment of benign pigmented lesions including: .
- Freckles Lentigines --
  - Poikloderma of Civatte Dennatosis Papulosis Nigra
- -Melasma Café- au- lait Stains ﺘ
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 ・
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

Regulation Number and Section

§ 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.