(326 days)
Not Found
No
The 510(k) summary describes a laser handpiece accessory for delivering laser energy for soft tissue ablation, vaporization, and coagulation. There is no mention of AI, ML, image processing, or any other computational technology that would suggest the use of AI/ML. The description focuses on the physical components and function of the handpiece.
Yes
The device is described as being used for "ablation, vaporization, and coagulation of soft tissue" and "Skin resurfacing," which are therapeutic actions to treat a condition or restore function.
No
The device description indicates its use in surgical applications for ablation, vaporization, and coagulation of soft tissue, primarily for skin resurfacing in Dermatology and Plastic Surgery, which are therapeutic rather than diagnostic actions.
No
The device description clearly outlines physical components (handpiece body, adapter attachments) and describes it as a "laser energy delivery device (accessory)," indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "surgical applications requiring the ablation, vaporization, and coagulation of soft tissue" using laser energy. This is a therapeutic and surgical application, not a diagnostic one.
- Device Description: The description details a laser energy delivery device (handpiece) that attaches to laser systems. This aligns with a surgical tool, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting markers, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is to deliver laser energy for surgical procedures.
N/A
Intended Use / Indications for Use
The Alma Lasers Family of Thermo-XEL Handpieces is intended for use in surgical applications requiring the ablation, vaporization, and coagulation of soft tissue for compatible CO2 and 2940 nm Er:YAG laser systems cleared for use in the medical specialty of Dermatology and Plastic Surgery to which they are attached.
The Alma Lasers Family of Thermo-XEL Handpieces is indicated for use in soft tissue for: DERMATOLOGY AND PLASTIC SURGERY: Skin resurfacing
Product codes
GEX
Device Description
The Alma Lasers Family of Thermo-XEL Handpieces is comprised of the following main components: Thermo-XEL Handpiece body. Adapter attachments: CO2 laser adapter attachment, as required, to attach the handpiece body to the qualified CO2 or Er: Y AG laser system Er:YAG laser adapter attachment, as required, to attach the handpiece body to the qualified Er: Y AG laser system. The Alma Lasers Family of Thermo-XEL Handpieces are provided as a non-sterile, cleanable, multiple use laser energy delivery device (accessory). The proximal end of the handpiece is designed to be attached, using the laser adapter, to the distal end of the articulated arm of compatible CO2 (10.6 um) or Er.YAG (2940 nm) laser systems as qualified by Alma Lasers for use with the Thermo-XEL Handpiece.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K063001, K022060, K963339, K951812, K070284, K042000, K072564
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
JUN 2 7 2008
Section 5 - 510(k) Summary or 510(k) Statement
I. General Information
| Submitter: | Alma Lasers, Ltd.
14 Halamish Street (PO Box 3021), Industrial Park,
Caesarea, 38900
ISRAEL |
|---------------------------|------------------------------------------------------------------------------------------------------|
| Contact Person: | Tatiana Epstein
Regulatory Affairs Manager |
| Summary Preparation Date: | June 12, 2008 |
II. Names
| Device Names: | Alma Lasers Family of Thermo-XEL Handpieces |
|---|---|
| --------------- | --------------------------------------------- |
Primary Classification Names: Accessory for, Laser Powered Surgical Instruments
III. Predicate Devices
- Lasering SLIM Evolution Family of CO2 Lasers and Accessories (K063001) .
- . Lumenis ActiveFx with UltraPulse Encore (K022060)
- . Lumenis UltraPulse with Scanner (K963339 and K951812)
- Reliant Technologies Fraxel SR1500 Laser Systems and Accessories (K070284) .
- . MSq Family of Lovely Light/Laser Systems (K042000)
- . Alma Lasers Harmony XL Multi-Application Platform and Thermoelectric Cooler (K072564)
IV. Product Description
The Alma Lasers Family of Thermo-XEL Handpieces is comprised of the following main components:
- Thermo-XEL Handpiece body .
- . Adapter attachments:
-
CO2 laser adapter attachment, as required, to attach the handpiece body to the qualified CO2 or Er: Y AG laser system
- ১ Er:YAG laser adapter attachment, as required, to attach the handpiece body to the qualified Er: Y AG laser system
-
The Alma Lasers Family of Thermo-XEL Handpieces are provided as a non-sterile, cleanable, multiple use laser energy delivery device (accessory). The proximal end of the handpiece is designed to be attached, using the laser adapter, to the distal end of the articulated arm of compatible CO2 (10.6 um) or Er.YAG (2940 nm) laser systems as qualified by Alma Lasers for use with the Thermo-XEL Handpiece.
1
V. Indications for Use
The Alma Lasers Family of Thermo-XEL Handpieces is intended for use in surgical applications requiring the ablation, vaporization, and coagulation of soft tissue for compatible CO2 and 2940 nm Er:YAG laser systems cleared for use in the medical specialty of Dermatology and Plastic Surgery to which they are attached.
The Alma Lasers Family of Thermo-XEL Handpieces is indicated for use in soft tissue for:
DERMATOLOGY AND PLASTIC SURGERY:
- � Skin resurfacing
VI. Rationale for Substantial Equivalence
The Alma Lasers Family of Thermo-XEL Handpieces shares the same or similar indications for use, operation, overall technical and functional capabilities, and therefore is substantially equivalent to the predicate devices.
VII. Safety and Effectiveness Information
The review of the indications for use and technical characteristics provided demonstrates that the Alma Lasers Family of Thermo-XEL Handpieces is substantially equivalent to the predicate devices.
VIII. Conclusion
The Alma Lasers Family of Thermo-XEL Handpieces was found to be substantially equivalent to the predicate devices.
The Alma Lasers Family of Thermo-XEL Handpieces shares the same or similar indications for use, similar design features, and functional features with, and thus is substantially equivalent to, the predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 7 2008
Alma Lasers Ltd. % A. Worden Consulting Ms. Anne Worden Regulatory Consultant 3637 Bernal Avenue Pleasanton, CA 94566
Re: K072182
Trade/Device Name: Alma Lasers Family of Thermo-XEL Handpieces 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: June 12, 2008 Received: June 13, 2008
Dear Ms. Worden:
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
3
Page 2 - Ms. Anne Worden
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.
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): K072182
Device Name: Alma Lasers Family of Thermo-XEL Handpieces
Indications for Use:
The Alma Lasers Family of Thermo-XEL Handpieces is intended for use in surgical applications requiring the ablation, vaporization, and coagulation of soft tissue for compatible CO2 and 2940 nm Er:YAG laser systems cleared for use in the medical specialty of Dermatology and Plastic Surgery to which they are attached.
The Alma Lasers Family of Thermo-XEL Handpieces is indicated for use in soft tissue for: DERMATOLOGY AND PLASTIC SURGERY:
· Skin resurfacing
V Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
FOR M. MATELKERSON
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K072182
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