(153 days)
Not Found
No
The summary describes a laser device for soft tissue procedures and does not mention any AI or ML components or functionalities.
No.
The device description indicates it is a laser for coagulation, vaporization, ablation, or cutting of soft tissue, which are surgical procedures, not therapeutic ones.
No
Explanation: The device description states its intended use is for "coagulation, vaporization, ablation, or cutting of soft tissue," which are treatment functions, not diagnostic ones.
No
The device description explicitly states it is an erbium: YAG laser, which is a hardware component.
Based on the provided information, the MCL 29 Dermablate laser is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "coagulation, vaporization, ablation, or cutting of soft tissue (skin)". This describes a direct surgical or therapeutic intervention 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. The MCL 29 Dermablate laser does not perform such tests.
- Device Description: The description of the device as an "erbium: YAG of power at 2.94um" further supports its function as a laser for tissue manipulation, not for analyzing biological samples.
Therefore, the MCL 29 Dermablate laser falls under the category of a therapeutic or surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MCL 29 Dermablate laser is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), and in oral and maxillofacial surgery, and ophthalmology (oculoplasty).
Product codes
GEX
Device Description
The MCL 29 Dermablate laser is an erbium: YAG of power at 2.94um.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), and in oral and maxillofacial surgery, and ophthalmology (oculoplasty).
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
None.
Key Metrics
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.
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MAR 1 7 1997
ATTACHMENT A
510 (k) SUMMARY
MCL 29 DERMABLATE ERBIUM LASER SYSTEM
This 510(k) summary of safety and effectiveness for the MCL 29 Dermablate erbium laser system 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.
AESCULAP-MEDITEC Applicant :
23832 Via Monte Address : 92679-4001 Coto De Caza, CA
Contact Person:
(of the Summary)
Mr. William T. Kelley AESCULAP-MEDITEC 23832 Via Monte Coto De Caza, CA 92679-4001
Telephone :
714-589-6259 (Fax)
October 3, 1996 Preparation Date:
MCL 29 Dermablate Er: YAG Laser System Device Trade Name:
714-589-8536
Erbium: Yttrium, Aluminum; Garnet (Er:YAG) Common Name: Laser System
Laser surgical instrument for use in Classification general and plastic surgery and in Name 21 CFR 878.4810). dermatology (see: Product Code: GEX .
Legally marketed Schwartz Electro-Optics, Inc. TriLase 2940 predicate devices Erbium Laser; Continuum Biomed, Inc., Multilite Erbium Laser System
The MCL 29 Dermablate laser is an Description of erbium: YAG of power at 2.94um. See below the Device: for additional specifications.
Intended Use of the The MCL 29 Dermablate laser is intended for MCL 29 Dermablate coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatollaser: ogy, plastic surgery (including aesthetic
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surgery), and in oral man surgery, and ophthalmology (oculoplasty).
This intended use is the same or similar to that for the claimed predicate devices (see below).
Comparison of specifications of MCL 29 Dermablate and the claimed predicate devices:
| Specification | MCL 29 Dermablate
Laser | TriLase 2940 Erbium
Laser | Multilite Erbium
Laser System |
|--------------------|------------------------------------------|----------------------------------|----------------------------------|
| Type of laser | Er: YAG | Er: YAG | Er: YAG |
| Power | 6 Watts maximum | 5 Watts maximum | |
| Wavelength | 2.94 um | 2.94 um | 2.94 um |
| Pulse width | 350 usec | 300 usec
(option: continuous) | 100-400 usec |
| Frequency | 5-15 Hz | 5-20 Hz | 1-10 Hz |
| Spot size | 1.6mm, 3mm, 5mm | Focusing handpiece | |
| mJ energy | 100-800 mJ | 1 J/pulse maximum | 30 mJ min., 1 J max. |
| Beam delivery | Articulated arm | Articulated arm | Articulated arm |
| Cooling | Water/air heat
exchanger | Internal heat
exchanger | Internal heat
exchanger |
| Aiming beam | 635 nm diode, 1 mW | 3 mW, red helium neon | 635 nm diode Because of this, performance data were not required.
CONCLUSION : Based on the foregoing and other information in this application, AESCULAP-MEDITEC believes that the MCL 29 Dermablate laser is substantially equivalent to legally marketed predicate devices, i.e., the Schwartz Electro-Optics, Inc. TriLase 2940 erbium laser (K954013) and the Continuum Biomed, Inc. Multilite erbium laser system (K961748).
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