(197 days)
Not Found
No
The provided 510(k) summary describes a laser device for surgical procedures and does not mention any AI or ML components, image processing, or data sets typically associated with AI/ML applications.
Yes
The device is used in surgical procedures and specific medical treatments like endovenous laser surgery and laser-assisted lipolysis, which aim to treat medical conditions.
No
The device is described as a laser intended for dermatologic and general surgical procedures, specifically for endovenous laser surgery, occlusion, and laser-assisted lipolysis. These are therapeutic procedures, not diagnostic ones. Although it cites IEC 60601-2-22, which mentions "diagnostic and therapeutic laser equipment," the intended uses listed for this specific device are all therapeutic.
No
The device description explicitly lists hardware components such as a main console unit, footswitch, and accessories, indicating it is a physical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use and Indications for Use: The intended use and indications clearly describe the device as a laser used for surgical procedures on the human body (endovenous laser surgery, laser assisted lipolysis). IVDs are used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description lists components like a main console unit, footswitch, and accessories, which are typical for a surgical laser device, not an IVD.
- Performance Studies: The performance studies mentioned are related to electrical safety and laser safety standards (IEC 60601 series, IEC 60825-1), which are relevant for medical devices used on patients, not for evaluating the analytical or clinical performance of an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or providing diagnostic information based on in vitro testing.
In summary, the Alma Diode Tabletop Laser is a therapeutic medical device used for surgical interventions, not a diagnostic device used for testing samples outside the body.
N/A
Intended Use / Indications for Use
The Alma Diode Tabletop Laser is intended for use in dermatologic and general surgical procedures.
Indications for Use
Diode Laser Modules:
The indications for use for the 810nm Alma Diode Tabletop Laser include:
- The Alma 810nm diode tabletop laser is indicated for endovenous laser surgery for saphenous incompetent veins.
The indications for use for the 980 nm Alma Diode Tabletop Laser include:
-The Alma 980nm diode tabletop laser is indicated for use in endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Alma 980nm diode tabletop laser is further indicated for laser assisted lipolysis.
The indications for use for the 1470nm Alma Diode Tabletop Laser include:
-The Alma 1470nm diode tabletop laser is indicated for use in endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Alma 1470nm diode tabletop laser is further indicated for laser assisted lipolysis.
Product codes
GEX
Device Description
The Alma Diode Tabletop Laser is comprised of the following major components:
-
- The main console unit
-
- Footswitch.
-
- Accessories
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
greater saphenous vein, 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)
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
JUL 1 8 2014
K140005
Section 8 - 510(k) Summary or 510(k) Statement
l, General Information
Submitter:
Alma Lasers, Ltd, Halamish St. POB 3021 Caesarea Industrial Park, Caesarea, Israel 38900
Contact Person:
Kathy Maynor Consultant 352-586-3113 (cell)
Summary Preparation Date:
Dec 30, 2013
- II. Names
| Device Names: | The Alma Diode Tabletop Laser |
|---|---|
| ---------------------- | ------------------------------- |
Surgical Powered Light Instrument, Primary Classification Names:
III. Predicate Devices
. Predicate Device ___________________________________________________________________________________________________________________________________________________________ K # ** K100058 Quanta Diode Laser Family
IV. Product Description
The Alma Diode Tabletop Laser is comprised of the following major components:
-
- The main console unit
-
- Footswitch.
-
- Accessories
V. Indications for Use
The Alma diode tabletop laser is intended for use in dermatologic and general surgical procedures.
1
VI. Summary of Technical Characteristics
.
| K13 | K100558 | |
|---|---|---|
| Alma diode tabletop laser | Quanta Diode Laser Family | |
| Parameter | ||
| Product Code & | ||
| Regulation No. | GEX | |
| 21 CFR 878.4810 | GEX | |
| 21 CFR 878.4810 | ||
| Laser Wavelength [nm] | 1470 | 1470 |
| Max power | 15W | 15W |
| Light/Laser Source | Diode | Diode |
| Laser Delivery | Optical Fiber | Optical Fiber |
| Operation Mode | Continuous wave, single pulse, pulsed | Continuous wave, single pulse, pulsed |
| Pulse Duration | 10-990ms | 3ms - 2.5s |
| Bare fiber size | 200, 300, 320, 400, 600, 800, 1000 | 200, 300, 320, 400, 600, 800, 1000 |
| User Interface | LCD touch screen | LCD touch screen |
| Aiming beam | 635nm | 650nm |
| Electrical Requirements | 100-240. V AC 50-60 Hz, 6.3 A | 100-240, V AC 50-60 Hz, 6.3 A, single phase, |
| Indications for Use | The Alma 1470nm diode tabletop laser is indicated for use in endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Alma 1470nm diode tabletop laser is further indicated for laser assisted lipolysis, | The QUANTA Diode Laser System is intended for delivery of laser light to soft tissue in the contact and non contact mode during surgical procedures including via endoscopes. The QUANTA Diode Laser System is generally indicated for use in endovenous occlusion of the greater saphenous vein in Patients with Superficial Vein Reflux. The QUANTA1470 Diode Laser is further indicated for laser assisted lipolysis |
.
.
.
Table 1: Salient Characteristics of the 1470nm module and the Predicate Devices
·
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:
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:
2
Table 2: Salient Characteristics of the 980nm module and the Predicate Devices
・
| K13 | K100558 | |
|---|---|---|
| Alma diode tabletop laser | Quanta Diode Laser Family | |
| Parameter | ||
| Product | ||
| Code & | ||
| Regulation | ||
| No. | GEX | |
| 21 CFR 878.4810 | GEX | |
| 21 CFR 878.4810 | ||
| Laser | ||
| Wavelength | ||
| [nm] | 980nm | 980nm |
| Max power | 30W | 30W |
| Light/Laser | ||
| Source | Diode | Diode |
| Laser | ||
| Delivery | Optical Fiber | Optical Fiber |
| Operation | ||
| Mode | Continuous wave, single | |
| pulse, pulsed | Continuous wave, single pulse, | |
| pulsed | ||
| Pulse | ||
| Duration | 10-990ms | 3ms - 2.5s |
| Bare fiber | ||
| size | 200, 300, 320, 400, 600, 800, | |
| 1000 | 200, 300, 320, 400, 600, 800, | |
| 1000 | ||
| User | ||
| Interface | LCD touch screen | LCD touch screen |
| Aiming beam | 635nm | 650nm |
| Electrical | ||
| Requirements | 100-240, V AC 50-60 Hz, 6.3 | |
| A, | 100-240, V AC 50-60 Hz, 6.3 A. | |
| single phase. | ||
| Indications | ||
| for Use | The Alma 980nm diode | |
| tabletop laser is indicated | ||
| for use in endovenous | ||
| occlusion of the greater | ||
| saphenous vein in patients | ||
| with superficial vein | ||
| reflux. The Alma 980nm | ||
| diode tabletop laser is | ||
| further indicated for laser | ||
| assisted lipolysis, | The QUANTA Diode Laser | |
| System is intended for delivery of | ||
| laser light to soft tissue in the | ||
| contact and non contact mode | ||
| during surgical procedures | ||
| including | ||
| via endoscopes. The QUANTA | ||
| Diode Laser System is generally | ||
| indicated for use in endovenous | ||
| occlusion of the greater | ||
| saphenous vein in Patients with | ||
| Superficial Vein Reflux. The | ||
| QUANTA980 Diode | ||
| Laser is further indicated for laser | ||
| assisted lipolysis. (This is a | ||
| subset of the cleared indications | ||
| for this product) |
·
・
.
: 3/5
·
3
Table 3: Salient Characteristics of 810nm diode module and the predicate devices
·
વે
| K13 | K100558 | |
|---|---|---|
| Alma diode tabletop laser | Quanta Diode Laser Family | |
| Parameter | ||
| Product | ||
| Code & | ||
| Regulation | ||
| No. | GEX | |
| 21 CFR 878.4810 | GEX | |
| 21 CFR 878.4810 | ||
| Laser | ||
| Wavelength | ||
| [nm] | 810nm | 808nm |
| Max power | 30W | 30W |
| Light/Laser | ||
| Source | Diode | Diode |
| Laser | ||
| Delivery | Optical Fiber | Optical Fiber |
| Operation | ||
| Mode | Continuous wave, single | |
| pulse, pulsed | Continuous wave, single pulse, | |
| pulsed | ||
| Pulse | ||
| Duration | 10-990ms | 3ms - 2.5s |
| Bare fiber | ||
| size | 200, 300, 320, 400, 600, 800, | |
| 1000 | 200, 300, 320, 400, 600, 800, | |
| 1000 | ||
| User | ||
| Interface | LCD touch screen | LCD touch screen |
| Aiming beam | 635nm | 650nm |
| Electrical | ||
| Requirements | 100-240, V AC 50-60 Hz, 6.3 | |
| A. | 100-240, V AC 50-60 Hz, 6.3 A, | |
| single phase, | ||
| Indications | ||
| for Use | The Alma 810nm diode | |
| tabletop laser is indicated | ||
| for endoluminal or | ||
| endovenous laser surgery | ||
| for saphenous incompetent | ||
| veins. | The QUANTA Diode Laser | |
| System is intended for delivery of | ||
| laser light to soft tissue in the | ||
| contact and non contact mode | ||
| during surgical procedures | ||
| including | ||
| via endoscopes. The QUANTA | ||
| 808 Diode Laser System is | ||
| generally indicated for | ||
| endoluminal or endovenous laser | ||
| surgery for saphenous | ||
| incompetent veins. (This is a | ||
| subset of the cleared indications | ||
| for this product). |
·
.
4 / 5
4
VII. Safety and Effectiveness Information
The review of the indications for use and technical characteristics provided demonstrates that the Alma diode tabletop laser is substantially equivalent to the predicate devices.
The Diode Tabletop Laser was tested by a certified laboratory according to:
IEC 60601-1: 1988+A1:1991+A2:1995: Medical Electrical Equipment Part 1: General Requirements for basic safety and essential performance
IEC 60601-1-2: Medical electrical equipment: Part 1-2: General requirements for safety-Collateral Standard: Electromagnetic compatibility - Requirements and tests (2001 + A1(4))
IEC 60601-2-22:1995 Medical electrical equipment- Part 2-22: Particular requirements for the safety of diagnostic and therapeutic laser equipment 1995.
IEC 60825-1:2007 (2nd edition) Safety of Laser Products-Part 1: Equipment Classification and Requirements
Conclusion VIII.
The Alma diode tabletop laser was found to be substantially equivalent to the predicate devices.
The Alma diode tabletop laser shares the same or similar indications for use, similar design features, and functional features with, and thus is substantially equivalent to the predicate devices.
5
Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings or feathers. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 18, 2014
Alma Lasers Ltd. % Ms. Kathy Maynor Regulatory Consultant for Alma LTD 26 Rebecca Court Homosassa. Florida 34446
Re: K140005
Trade/Device Name: The Alma Diode Tabletop Laser Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: April 29, 2014 Received: June 20, 2014
Dear Ms. Maynor:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 that I DA has intatutes and regulations administered by other Federal agencies. You must or any reath all the Act s requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
6
Page 2 - Ms. Kathy Maynor
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
| 510(k) Number (if known) | K140005 |
|---|---|
| -------------------------- | --------- |
Device Name The Alma Diode Tabletop Laser
Indications for Use (Describe) Intended Use The Alma Diode Tabletop Laser is intended for use in dermatologic and general surgical procedures.
Indications for Use The Alma Diode Tabletop Laser includes three possible diode laser modules depending on the customer order.
Diode Laser Modules:
The indications for use for the 810nm Alma Diode Tabletop Laser include:
- The Alma 810nm diode tabletop laser is indicated for endovenous laser surgery for saphenous incompetent veins.
The indications for use for the 980 nm Alma Diode Tabletop Laser include:
-The Alma 980nm diode tabletop laser is indicated for use in endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Alma 980nm diode tabletop laser is further indicated for laser assisted lipolysis.
The indications for use for the 1470nm Alma Diode Tabletop Laser include:
-The Alma 1470nm diode tabletop laser is indicated for use in endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Alma 1470nm diode tabletop laser is further indicated for laser assisted lipolysis.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Neil R Ogden -S 2014.07.17 16:13:51 -04′00″