Identity
- Trade Name
- MEL 80 FDA UDI
- Generic Name
- Ophthalmic excimer laser system FDA UDI
- Device Name
- The MEL 80 Excimer Laser System is indicated for use in primary Laser Assisted in situ Keratomileusis (LASIK) treatments for the reduction or elimination of - myopia of less than or equal to -7.0 D with or without refractive astigmatism of less than or equal to -3.0 D, with a Maximum MRSE of -7.0 D - naturally occurring hyperopia of less than or equal to +5.0 D with or without refractive astigmatism of greater than +0.5 D and less than or equal to +3.0 D, with a maximum MRSE of +5.0 D in patients who are 21 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by Change in sphere and cylinder of 0.5 D. FDA UDI
- Model / Reference
- MEL 80 FDA UDI
- Description
- The MEL 80 Excimer Laser System is indicated for use in primary Laser Assisted in situ Keratomileusis (LASIK) treatments for the reduction or elimination of - myopia of less than or equal to -7.0 D with or without refractive astigmatism of less than or equal to -3.0 D, with a Maximum MRSE of -7.0 D - naturally occurring hyperopia of less than or equal to +5.0 D with or without refractive astigmatism of greater than +0.5 D and less than or equal to +3.0 D, with a maximum MRSE of +5.0 D in patients who are 21 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by Change in sphere and cylinder of 0.5 D. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049471000221 FDA UDI
- PMA Number
- P060004 FDA UDI
- FDA Product Code
- LZS FDA UDI
- GMDN Term
- Ophthalmic excimer laser system FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Weight — 260 Kilogram FDA UDI
Category: Ophthalmic excimer laser system
Mel 80 by Carl Zeiss Meditec AG — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic excimer laser system.
- WAVELIGHT EX500 EXCIMER LASER — Alcon Laboratories, Inc. · Class III
- Quest™ — Nidek, Inc. · Class III
- Final Fit™ — Nidek, Inc. · Class III
- Final Fit™ — Nidek, Inc. · Class III
- Final Fit — Nidek, Inc. · Class III
- STAR S4 IR — Johnson & Johnson Surgical Vision, Inc. · Class III
- MEL 90 — Carl Zeiss Meditec AG · Class III
Cleared under the same submission
P060004 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Carl Zeiss Meditec AG
Sources (1)
- FDA UDI 7819b6e3-b608-4afa-be04-8838d35be1a7 36 fields · synced May 31, 2026