(81 days)
Medical Laser Technology-Inc. M.L.T. 30
Not Found
No
The 510(k) summary describes a standard CO2 laser for soft tissue ablation and does not mention any AI or ML components, image processing, or performance studies related to algorithmic analysis.
Yes
The device is intended for the ablation, vaporization, incision, excision, or cutting of soft tissue, which are actions typically performed for therapeutic purposes.
No
Explanation: The device is described as a CO2 laser intended for surgical procedures such as ablation, vaporization, incision, excision, or cutting of soft tissue. These are therapeutic, not diagnostic, actions.
No
The device description clearly states it is a CO2 laser which emits a beam of coherent light, 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 the "ablation, vaporization, incision, excision, or cutting of soft tissue" in various surgical specialties. This describes a therapeutic or surgical intervention 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 description focuses on the laser's function in emitting light for tissue manipulation, not for analyzing biological samples.
Therefore, the Aesculap-Meditec CO2 Laser is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Aesculap-Meditec 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 Aescular-Mediter CO2 laser is intended for the ablation, vaporization, incision, excision, and or cutting of soft tissue in:
Oral surgery
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 (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Aesculap-Meditec MultiPulse-CO2 laser emits a beam of coherent light at 10.6 microns.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
soft tissue
oral surgery
E.N.T.
gynecology
dermatology
skin
larynx
pharynx
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Aesculap-Meditec proposes that the MultiPulse CO2 laser be limited to prescription use.
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)
Performance Data: None. The specifications and indications for use of the Aesculap-Meditec MultiPulse CO2 laser are the same or very similar to those of the claimed predicate device.
Because of this, performance data were not required:
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Medical Laser Technology-Inc. M.L.T. 30
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 AESCULAP-MEDITEC MULTIPULSE CO, LASER
X |
| --------------------------------------- | ---------------------------------------- |
|---|
OR
| Over-The-Counter Use | ____________________ |
|---|---|
| ---------------------- | ---------------------- |
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K983215 |