(76 days)
Not Found
Not Found
No
The summary describes a standard CO2 surgical laser system and does not mention any AI or ML components or functionalities.
Yes
The device is intended for clinical use in the ablation, vaporization, excision, incision, and coagulation of soft tissue to treat various medical conditions and improve patient health, which aligns with the definition of a therapeutic device.
No
The device is described as a surgical laser system intended for the ablation, vaporization, excision, incision, and coagulation of soft tissue, which are all therapeutic actions, not diagnostic ones.
No
The device description explicitly states it is a "carbon dioxide laser that utilizes a radio frequency amplifier" and delivers treatment through "an articulated arm or a hollow wave guide," indicating it is a hardware-based system, not software-only.
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, or tissue) to provide information about a person's health.
- Device Function: The OrLight 2000 CO2 Surgical Laser System is a surgical laser used for directly treating soft tissue through ablation, vaporization, excision, incision, and coagulation. It physically interacts with the tissue.
- Lack of Diagnostic Testing: The description does not mention any function related to analyzing samples or providing diagnostic information. Its purpose is therapeutic and surgical.
Therefore, the OrLight 2000 CO2 Surgical Laser System falls under the category of a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
GEX
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.
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
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.
Key Metrics
Not Found
Predicate Device(s)
Coherent Ultrapulse Carbon Dioxide Lasers, Sharplan Carbon Dioxide SilkLaser
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
Laser System
Premarket Notification February 2, 1999
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):
1
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.
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.
2
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.
3
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
4
Page _ of _
510(k) Number (if known): K990452
Device Name: Or Light 2000 Surgical Laser System
Indications For Use:
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.
(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)