(90 days)
Not Found
Not Found
No
The summary describes a standard CO2 laser device and does not mention any AI or ML components, image processing, or performance studies related to algorithmic performance.
Yes
The device is described as a CO2 laser intended for the ablation, vaporization, incision, and cutting of soft tissue in various medical fields, indicating a direct therapeutic action on the body.
No
The device is described as a CO2 laser intended for ablation, vaporization, incision, and cutting of soft tissue. These are therapeutic actions, not diagnostic ones. Diagnostic devices are used to identify the nature or cause of a disease or condition.
No
The device description explicitly states it is a CO2 laser which emits a beam of coherent light, indicating it is a hardware device, not software-only.
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 the "ablation, vaporization, incision, and or cutting of soft tissue" in various surgical specialties. This describes a therapeutic or surgical intervention performed directly on the patient's body.
- Device Description: The description mentions emitting a beam of coherent light for tissue interaction. This is consistent with a surgical laser, not a device used to examine samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) or providing diagnostic information based on such analysis. IVDs are designed to diagnose diseases or conditions by testing samples in vitro (outside the living organism).
Therefore, the M.L.T. 30 CO2 laser is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CO2 Laser is intended for the ablation, vaporization, incision, excision, or cutting of soft tissue in oral surgery, E.N.T., gynecology, and dermatology.
The M.L.T. 30 CO2 laseris intended for the ablation, vaporization, incision, and or cutting of soft tissue in:
Oral surgery
Dermatology
Examples: Removal of small skin tumors, superficial pigmented lesions, adeno-sebaceous hypertrophy, treatment of scars, skin tags, etc.
Skin resurfacing (scanning mode)
Blepharoplasty
E.N.T.
Examples: Tumor surgery of the larynx and pharynx
LAUP
Stenosis
CAUTION: Patients should be diagnosed with tissue problems to exclude those whose problems are caused by being overweight or to drinking problems. Remind patients that there may be vocalization problems after laser surgery.
Gynaecology
The examples are not intended to be exhaustive or complete but to serve as a general guide to the surgeon.
Product codes
GEX
Device Description
The Medical Laser Technologies Ltd. MLT 30 CO2 Laser emits a beam of coherent light at 10.6 microns.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral surgery, E.N.T. (larynx and pharynx), gynecology, and dermatology (skin).
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Per 21 CFR 801.109)
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 Meditec Laser Technologies Ltd. 30 CO, laser are the same or very similar to those of the claimed predicate devices. Because of this, performance data were not required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Medical Laser Technology, Inc. M.L.T. 30 CO, Laser
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
APPENDIX E
510(k) SUMMARY MEDICAL LASER TECHNOLOGIES LTD MLT 30 CO, LASER
This 510(k) summary of safety and effectiveness for the Medical Laser Technologies Ltd. MLT 30 CO2 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: MEDICAL LASER TECHNOLOGIES LTD
- Address: Unit 4 Belleknowes Industrial Estate Inverkeithing Fife KY11 1HY United Kingdom
- Contact Person: David Hamilton Managing Director
- Telephone: +44 1383 411555 +44 1383 411666 (Fax)
Preparation Date: July 1998 (of the Summary)
Device Name: MLT 30 CO. Laser
Common Name: CO2 Laser
Classification Laser surgical instrument for use in general and plastic surgery and in Name: dermatology (see: 21 CFR 878.4810). Product Code: GEX. Panel: 79
Legally marketed Medical Laser Technology, Inc. M.L.T. 30 CO, Laser predicate device:
The Medical Laser Technologies Ltd. MLT 30 CO2 Laser emits a beam of Description of the Device: coherent light at 10.6 microns.
- Indications for The CO2 Laser is intended for the ablation, vaporization, incision, excision, use: or cutting of soft tissue in oral surgery, E.N.T., gynecology, and dermatology.
012
1
The specifications of and indications for the Medical Laser Technologies Ltd. Comparison to: 30 CO2 Laser are the same as or very similar to those of the claimed predicate, the M.L.T. 30 marketed by Medical Laser Technology, Inc.
Performance Data: None: The specifications and indications for use of the Meditec Laser Technologies Ltd. 30 CO, laser are the same or very similar to those of the claimed predicate devices.
Because of this, performance data were not required.
- CONCLUSION: Based on the similarities of specifications and indications for use for ablation, vaporization, incision, excision, or cutting of soft tissue in a number of surgical specialties Medical Laser Technologies Ltd. believes that the 30 CO2 Laser described in this notification is substantially equivalent to the cited legally marketed predicate device.
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 or bird-like symbol on the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 9 1998
Medical Laser Technologies, Ltd. c/o Mr. William Kelley 23832 Via Monte Coto De Caza, California 92679-4001
K982548 Re: MLT 30 Trade Name: II Regulatory Class: Product Code: GEX July 21, 1998 Dated: Received: July 21, 1998
Dear Mr. Kelley:
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 aqainst 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ಗಿ 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 requlations.
3
Page 2 - Mr. William Kelley
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 gener 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,
Celia M. Witten, Ph.D., M.D.
Director
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
APPENDIX B rev. 10/98
INDICATIONS FOR USE STATEMENT
| 510(K) Number (if known): | K982548 |
|---|---|
| Device Name: | M.L.T. 30 CO₂ laser |
Indications For Use Statement:
The M.L.T. 30 CO2 laseris intended for the ablation, vaporization, incision, and or cutting of soft tissue in:
| Oral surgery
| Dermatology | |
|---|---|
| Examples: Removal of small skin tumors, superficial pigmented lesions, adeno- | |
| sebaceous hypertrophy, treatment of scars, skin tags, etc. | |
| Skin resurfacing (scanning mode) | |
| Blepharoplasty | |
| E.N.T. | |
| Examples: Tumor surgery of the larynx and pharynx | |
| LAUP | |
| Stenosis | |
| CAUTION: Patients should be diagnosed with tissue problems to exclude those | |
| whose problems are caused by being overweight or to drinking | |
| problems. | |
| Remind patients that there may be vocalization problems after laser | |
| surgery. |
Gynaecology
The examples are not intended to be exhaustive or complete but to serve as a general guide to the surgeon.
Meditec Laser Fechnologies proposes that the M.L.T. 30 CO2 laser be limited to prescription use. This labeling will be included in the final printing of the manual and on literature relating to the device.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (OFFICE OF DEVICE EVALUATION)
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| ------------------------------------------ | ------------------------------------------ | ---------------------- |
Division Sign-Off
of General Restorative Devices
510(k) Number: K982548