The OrLight 2000 CO2 Surgical Laser System is intended for use in the ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery, including aesthetic surgery and resurfacing. The specific indications are as follows:

Ablation, vaporization, excision, incision, and coagulation of soft tissue in laser skin resurfacing, laser derm-abrasion, and laser burn debridement.
Laser skin resurfacing (ablation and/or vaporization) for the treatment of wrinkles, rhytids, and furrows.
Laser skin resurfacing (ablation, vaporization, excision, incision, and coagulation) for the reduction, removal and/or treatment of actinic keratosis, solar/actinic elastosis, actinic cheilitis, lentinges, uneven pigmentation/dyschromia, acne scars, surgical scars, keloids, hemangiomas, tattoos, telangiectasia, squamous cell carcinoma, epidermal nevi, xanthelasma palpebrarum, syringoma, and verrucae vulgares (warts).
Laser incision and/or excision of soft tissue for the performance of laser blepharoplasty.

Device Description

The OrLight 2000 Surgical Laser system is a carbon dioxide laser that utilizes a radio frequency amplifier. Laser treatment is delivered to the target tissue through an articulated arm or a hollow wave guide.

AI/ML Overview

This submission, K990452, for the OrLight 2000 Surgical Laser System, is a Premarket Notification (510(k)) from February 2, 1999. This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than proving its safety and effectiveness through extensive clinical trials with acceptance criteria in the way a Pre-Market Approval (PMA) would. Therefore, the information provided focuses on comparative testing and compliance with safety standards rather than detailed acceptance criteria and standalone performance studies with specific statistical metrics.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided document, specific quantitative acceptance criteria for device performance, such as a minimum sensitivity or specificity, are not explicitly stated as would be expected for a PMA or an AI/ML device. The submission focuses on demonstrating substantial equivalence to predicate devices, primarily through engineering and comparative performance.

Acceptance Criterion (Implicit)	Reported Device Performance
Equivalence in Soft Tissue Ablation	"The OrLight 2000 Surgical Laser System was found to perform equivalently to the predicate devices with respect to soft tissue ablation."
Compliance with Applicable Safety Standards	"The OrLight 2000 Surgical Laser System has been designed and tested to applicable safety standards."
Similar Design Features	"The OrLight 2000 Surgical Laser System has similar design features... as the predicate, legally marketed devices (Sharplan and Coherent carbon dioxide lasers)."
Similar Functional Features	"The OrLight 2000 Surgical Laser System has similar... functional features... as the predicate, legally marketed devices (Sharplan and Coherent carbon dioxide lasers)."
Similar Laser Parameters	"The OrLight 2000 Surgical Laser System has similar... laser parameters as the predicate, legally marketed devices (Sharplan and Coherent carbon dioxide lasers)."
Intended Use Equivalence	The intended uses are listed and align with the general capabilities and uses of the predicate devices for soft tissue ablation, vaporization, excision, incision, and coagulation in dermatology and plastic surgery.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: The document does not specify a sample size for a "test set" in the context of clinical performance data. The evaluation appears to be based on engineering tests and comparisons to predicate devices in terms of general performance characteristics and safety.
Data Provenance: Not applicable in the context of a clinical test set. The data presented is likely from internal engineering tests and comparisons, rather than a clinical study with patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This information is not applicable as the submission does not describe a clinical study with a "test set" requiring expert-established ground truth for diagnostic accuracy, which is common for AI/ML devices. The "ground truth" for this device would be its ability to perform the stated laser functions effectively and safely, which is assessed through non-clinical testing.

4. Adjudication Method for the Test Set:

Not applicable. There is no mention of a "test set" or adjudication method for clinical performance.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. This type of study assesses the impact of an AI algorithm on human reader performance, which is relevant for diagnostic or interpretive AI devices. The OrLight 2000 is a surgical laser system, a therapeutic device, not a diagnostic or AI-driven interpretive tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

No, a standalone performance study in the context of an AI algorithm was not done. The device itself is a standalone laser system, and its "performance" is evaluated through its physical characteristics, safety, and ability to perform soft tissue ablation, rather than an algorithmic output.

7. Type of Ground Truth Used:

The "ground truth" for this device's performance is implicit in its ability to physically ablate, vaporize, excise, incise, and coagulate soft tissue as intended, and in its compliance with safety standards. This is verified through non-clinical laboratory testing (e.g., measuring laser parameters, tissue interaction studies) rather than pathology, outcomes data, or expert consensus on a diagnostic outcome.

8. Sample Size for the Training Set:

Not applicable. The OrLight 2000 Surgical Laser System is a hardware device; it does not involve AI or algorithms that require a "training set" of data.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As the device is not an AI/ML algorithm, there is no training set or associated ground truth establishment process.

Summary

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Laser System

Premarket Notification February 2, 1999

K990452

SECTION 7

5104 SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Submitter's name, address, telephone number, contact person, and date 1. summary prepared:
- a. Y-Beam Technologies, Inc. 216 Technology Drive, Suite L Irvine, CA 92618
- Joseph Neev, Ph.D. b. Contact Person: President
- January 20, 1999 Date Summary Prepared: C.

2. Name of device, including trade name and classification name:

a. Trade/Proprietary Name:	OrLight 2000 Surgical Laser System
b. Classification Name:	Surgical laser system (21 CFR 878.4810

Identification of the predicate device or legally marketed device or devices to 3. which substantial equivalence is being claimed:

The OrLight 2000 Surgical Laser is substantially equivalent to the following predicate devices : Coherent Ultrapulse Carbon Dioxide Lasers and Sharplan Carbon Dioxide SilkLaser.

A description of the device that is the subject of the 510(k), including 4. explanation of how the device functions, basic scientific concepts, significant physical and performance characteristics (design, material, physical properties):

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5. Statement of intended use:

The OrLight 2000 Surgical Laser System is intended for use in the ablation, vaporization, excision, incision and coagulation of soft tissue in dermatology and plastic surgery, including aesthetic surgery and resurfacing.

Statement of how the technological characteristics of the device compare to 6. those of the predicate or legally marketed device:

The OrLight 2000 Surgical Laser System has similar design features, functional features, and laser parameters as the predicate, legally marketed devices (Sharplan and Coherent carbon dioxide lasers).

7. Brief summary of nonclinical tests and results:

The OrLight 2000 Surgical Laser System has been designed and tested to applicable safety standards. In addition, the OrLight 2000 Surgical Laser System was found to perform equivalently to the predicate devices with respect to soft tissue ablation.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often used as a symbol of medicine. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 9 1000

Y-Beam Technologies, Inc. c/o Dr. Judy F. Gordon, D.V.M. Judy Gordon Consulting 18732 Saginaw Drive Irvine, California 92612

K990452 Trade Name: OrLight 2000 Surgical Laser System Regulatory Class: II Product Code: GEX Dated: February 2, 1999 Received: February 12, 1999

Dear Dr. Gordon:

Re:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 – Dr. Judy F. Gordon

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

[signature]

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page _ of _

510(k) Number (if known): K990452

Device Name: Or Light 2000 Surgical Laser System

Indications For Use:

Ablation, vaporization, excision, incision, and coagulation of soft tissue in ● laser skin resurfacing, laser derm-abrasion, and laser burn debridement.
Laser skin resurfacing (ablation and/or vaporization) for the treatment of . wrinkles, rhytids, and furrows.
Laser skin resurfacing (ablation, vaporization, excision, incision, and ● coagulation) for the reduction, removal and/or treatment of actinic keratosis, solar/actinic elastosis, actinic cheilitis, lentinges, uneven pigmentation/dyschromia, acne scars, surgical scars, keloids, hemangiomas, tattoos, telangiectasia, squamous cell carcinoma, epidermal nevi, xanthelasma palpebrarum, syringoma, and verrucae vulgares (warts).
Laser incision and/or excision of soft tissue for the performance of laser . blepharoplasty.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K990452

Prescription Use(Per 21 CFR 801/109)	X	OR	Over-The-Counter Use
------------------------------------------	---	----	----------------------

(Optional Format 1-2-96)

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.