MEL 90
Basic Information
- Brand Name
- MEL 90
- Primary DI
- 04049471095074
- Version / Model
- 1900-109
- Company Name
- Carl Zeiss Meditec AG
- Labeler DUNS
- 314594680
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-12-13
- Public Version
- 1
- Public Version Date
- 2024-12-23
- Public Version Status
- New
- Public Device Record Key
- 162179b1-b91d-42b7-be4d-00f613370095
Device Description
The Carl Zeiss Meditec MEL 90 Excimer Laser System is designed for refractive surgery based on the ablation of corneal tissue achieved with a short pulse excimer laser having a wavelength of 193 nanometers. The laser head emits 4 to 7 nanosecond pulses (FWHM nominal pulse duration) with a repetition rate of 500 Hz. The MEL 90 Excimer Laser is a spot-scanning laser that utilizes a Gaussian beam with a 0.7 mm spot diameter. Indications for Use: The MEL 90 is indicated for use in primary Laser-Assisted in situ Keratomileusis (LASIK) treatments for the reduction or elimination of: • Myopia less in magnitude than -10.00 D sphere (in minus-cylinder notation), with and without cylinder up to -4.00 D, when MRSE is less in magnitude than -10.00 D; • Hyperopia up to +4.00 D sphere (in plus-cylinder notation), with and without cylinder up to +3.00 D, when MRSE is up to +5.00 D; and • Mixed astigmatism with cylinder from >1.00 D up to 4.00 D; in patients who are 18 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by a change in MRSE within +/- 0.50 D.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LZS | Excimer Laser System | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17702 | Ophthalmic excimer laser system | A mains electricity (AC-powered) device assembly in which input energy is used to excite an excimer gas to emit a high-power laser beam intended for corneal ablation (i.e., photorefractive keratectomy) and other ophthalmologic procedures (e.g., surgical creation of a communication between the lacrimal sac and the nasal cavity). It includes a light source and controls/foot-switch, and is typically coupled to a biomicroscope slit lamp or to an indirect ophthalmoscope by a flexible fibreoptic cable. It does not include femtosecond pulsing or fundus imaging technology. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04049471095074 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P060004 | 006 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 295 | Kilogram | |
| Device Size Text, specify | x W x H: 1.63 m x 0.73 m x 1.48 m to 1.70 m |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 18 – 24 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 0 – 50 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Storage Environment Temperature
- Temperature Range
- -15 – 40 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal