(90 days)
K#954013, K#970461, K#014057
Not Found
No
The document describes a standard Er:YAG laser system and does not mention any AI or ML components, image processing, or data-driven performance metrics.
Yes.
The device is used for medical treatment such as coagulation, vaporization, ablation, and cutting of soft tissue, which falls under the definition of a therapeutic device.
No
Explanation: The device description states its intended use is for "coagulation, vaporization, ablation, or cutting of soft tissue," which are treatment procedures, not diagnostic ones.
No
The device description explicitly states it is a laser system consisting of a cabinet, umbilical cables, and a handpiece, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "coagulation, vaporization, ablation, or cutting of soft tissue (skin)". This describes a therapeutic or surgical procedure performed directly on the patient's body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform such tests.
- Device Description: The device description details a laser system used for direct tissue interaction, not for analyzing biological samples.
Therefore, the International Biophysics Corporation Laser Peel system is a therapeutic or surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The International Biophysics Corporation Laser Peel System is intended for coagulation, vaporization, ablation, or cutting of soft tissue(skin) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and opthamology.
Product codes
GEX
Device Description
The International Biophysics Corporation Laser Peel System is an Er:YAG laser producing emission at a wavelength of 2940 nm. The laser consist of two interconnected sections: The cabinet which houses the power supply, the cooling system and the electronics, and; the umbilical cables and the hand piece, which houses the laser.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue (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)
Nonclinical Performance Data: None Required
Clinical Performance data: None Required
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K#954013, K#970461, K#014057
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
K 030181
Attachment I
510(K) Summary International Biophysics Corporation Laser Peel System
APR 1 7 2003
This 510(K) Summary of safety and effectiveness for the IBC Laser Peel System is submitted in accordance with the requirements of SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.
| Applicant: | International Biophysics Corporation |
|---|---|
| Address: | 4020 S. Industrial Drive, Suite 160 |
| Austin, Texas 78744 | |
| Contact Person: | Len Hickey, Manager of Regulatory Affairs |
| Telephone: | |
| Telefax: | (512) 326-3244 |
| (512) 326-3299 | |
| Preparation Date: | 01/07/03 |
| Device Trade Name: | International Biophysics Corporation (IBC) Laser Peel |
| Common Name: | Erbium:YAG laser devise |
| Classification Name: | Instrument, Powered, Laser |
| 79-GEX | |
| 21 CFR 878-48 | |
| Legally Marketed Predicate | |
| Device | Schwartz Electro-Optics TriLase 2940, K#954013 |
| Cell Robotics Er:YAG Laser System, K#970461 | |
| Asceplion-Meditec Dermastar Er: Y AG Laser System, K#014057 | |
| Description of the Device | The International Biophysics Corporation Laser Peel |
| System is an Er:YAG laser producing emission at a wavelength | |
| of 2940 nm. The laser consist of two interconnected sections: | |
| The cabinet which houses the power supply, the cooling system | |
| and the electronics, and; the umbilical cables and the hand piece, | |
| which houses the laser. | |
| Intended Use of the Device | The International Biophysics Corporation Laser Peel |
| System is intended for coagulation, vaporization, ablation, or | |
| cutting of soft tissue(skin) in dermatology, plastic surgery | |
| (including aesthetic surgery), oral surgery, and opthamology. |
1
| Nonclinical Performance
| Data: | None Required |
|---|---|
| Clinical Performance data | None Required |
| Conclusion: | The International Biophysics Corporation Laser Peel |
| System is substantially equivalent to other existing legally | |
| marketed laser systems currently in commercial | |
| distribution. | |
| Additional Information: | None requested at this time |
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2
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three horizontal lines representing its wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
APR 1 7 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Len Hickey Manager of Regulatory Affairs International Biophysics Corporation 4020 S. Industrial Drive, Suite 160 Austin, Texas 78744
Re: K030181 Trade/Device Name: International Biophysics Corporation (IBC) Laser Peel 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: January 7, 2003 Received: January 17, 2003
Dear Mr. Hickey:
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 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.
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Page 2 - Mr. Len Hickey
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 Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. 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 vours.
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
4
INDICATION FOR USE STATEMENT
510(K) Number: K030181
Device Name: International Biophysics Corporation Laser Peel System
Indications for Use:
The International Biophysics Corporation Laser Peel system is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthalmology.
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Millman
ision Sign-Off) sion of General, Restorative urological Devices
510
j(k) Number K030181
Prescription Use OR
(per 21 CFR 801.109)
Over-the-Counter Use ------------