(78 days)
Not Found
No
The summary describes a standard surgical laser with no mention of AI or ML capabilities, image processing, or data sets for training/testing.
Yes
The device is indicated for medical procedures such as incision, excision, vaporization, and hemostasis of soft tissue, which are therapeutic actions.
No.
The device's stated indications for use are "incision, excision, vaporization, ablation, cutting, hemostasis and coagulation of soft tissue," which are all therapeutic procedures, not diagnostic ones.
No
The device description explicitly states it is a "semiconductor diode laser operating at 810 + 20 microns," which is a hardware component.
Based on the provided information, the LaserLite diode surgical laser is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for surgical procedures on soft tissue within the body (incision, excision, vaporization, etc.).
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
- Device Description: The description focuses on the laser's physical properties and function as a surgical tool, not on analyzing biological samples.
The LaserLite is a surgical device used on the patient, not a diagnostic tool used on samples from the patient.
N/A
Intended Use / Indications for Use
The LaserLite diode surgical laser is indicated for incision, excision, vaporization, ablation, cutting, hemostasis and coagulation of soft tissue in dermatology and plastic surgery, including aesthetic surgery.
Product codes
GEX
Device Description
The LaserLite diode surgical laser is a semiconductor diode laser operating at 810 + 20 microns.
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)
None. The specifications and indications for use of the LaserLite diode surgical laser are the same or very similar to those of the claimed predicate devices. The LaserLite diode surgical laser has many of the same indications for use which the claimed predicates have been cleared and has no additional indications for use. Because of this, performance data were not required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Diomed Surgical Lasers, K962354
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
. . .
APR - 3 1998
510(k) SUMMARY LASERLITE DIODE SURGICAL LASER
This 510(k) summary of safety and effectiveness for the diode surgical laser is submitted in accordance with the requirements of SMDA 1990 and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.
| Applicant: | LaserLite |
|---|---|
| Address: | 30-31 Union Wharf |
| Third Floor | |
| Boston, MA 02109 | |
| Contact Person: | David F. Muller, Ph.D. |
| President | |
| Telephone: | 617-720-5254 |
| 617-720-5260 (Fax) | |
| Preparation | |
| Date: | |
| (of the Summary) | February, 1998 |
| Device Name: | LaserLite Diode Surgical Laser |
| Common Name: | Surgical Laser: GaA1As Semiconductor Diode Laser |
| Classification | |
| Name: | Laser surgical instrument for use in general and plastic surgery and in |
| dermatology (see: 21 CFR 878.4810). Produce Code: GEX. Panel: 79. | |
| Legally marketed | |
| predicate devices: | Diomed Surgical Lasers |
| Description of the | |
| Device: | The LaserLite diode surgical laser is a semiconductor diode laser operating |
| at 810 + 20 microns. | |
| Indications for Use: | The LaserLite diode surgical laser is indicated for incision, excision, vaporization, |
| ablation, cutting, hemostasis and coagulation of soft tissue in dermatology and plastic | |
| surgery, including aesthetic surgery. | |
| Comparison to: | The specifications of the LaserLite diode surgical laser are the same as or |
| very similar to those of the claimed predicates (e.g., the Diomed Diode 60W laser | |
| K962354). | |
| Performance data: | None. The specifications and indications for use of the LaserLite diode surgical laser are |
| the same or very similar to those of the claimed predicate devices. The LaserLite diode | |
| surgical laser has many of the same indications for use which the claimed predicates have | |
| been cleared and has no additional indications for use. | |
| Because of this, performance data were not required. | |
| Conclusion: | Based on the foregoing, LaserLite believes that the LaserLite diode surgical laser is |
| substantially equivalent to legally marketed predicate devices. |
1
K980142, LaserLite Diode Surgical Laser
Image /page/1/Figure/1 description: This image shows a diagram of a 2mm handpiece. The diagram includes labels for the different parts of the handpiece, including the spacer bar, window, lens, laser beam, diverging laser beam, and fiber. The diagram provides a visual representation of the handpiece's components and their arrangement.
LA SERLITE HAND PIECE
Figure 1
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and three wavy lines below it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circle around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 3 1908
David F. Muller, Ph.D. President LaserLite 30-31 Union Wharf Third Floor Boston, Massachusetts 02109
K980142 Re: LaserLite Diode Surgical Laser Trade Name: Requlatory Class: II Product Code: GEX Dated: January 15, 1998 Received: January 15, 1998
Dear Dr. Muller:
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 The general controls provisions of the Act 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 Requlations, 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 In addition, FDA may publish further announcements action. 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. Muller
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,
J. Collyer
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
510(k) Number: K980142
Device Name: LaserLite Diode Surgical Laser
Indications for Use:
The LaserLite diode surgical laser is indicated for incision, excision, vaporization, ablation, cutting, hemostasis and coagulation of soft tissue in dermatology and plastic surgery, including aesthetic surgery.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_X
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number