| Primary Device ID | 03700542625224 |
| NIH Device Record Key | 20c18316-39a9-4822-b8ea-3c760f381af8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 532nm Heine Omega IO with integrated adaptor |
| Version Model Number | IOH810532 |
| Company DUNS | 738574953 |
| Company Name | QUANTEL MEDICAL |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| 03700542625958 - CAPSULO | 2025-04-02 Capsulo is indicated for photodisruption of ocular tissue using light energy emitted by a Nd. Yag laser, including discission of |
| 03700542626009 - POCKET III | 2025-04-02 The POCKET III unit is an ultrasonic pachymeter intended to be used for the measurement of corneal thickness by ultrasonic means |
| 03700542625569 - VITRA 2 | 2022-01-06 The VITRA 2 is a laser system which emits a treatment beam at 532 nm and is intended for use in photocoagulation of ocular tissu |
| 03700542625613 - VITRA 810 | 2022-01-06 The Vitra 810 is a laser system which emits a treatment beam at 810 nm and is intended for use in photocoagulation of ocular tis |
| 03700542625927 - EASYRET | 2021-10-27 The laser (577 nm Fiber Techology Laser SingleSpot, MultiSpot and Subliminal mode and Slit Lamp Zeiss mode) is a photocoagulator |
| 03700542625132 - VITRA | 2021-04-21 Ophthalmic Laser Photocoagulator
532nm MonoSpot Laser
Retinal Photocoagulation |
| 03700542625286 - SUPRA | 2021-04-21 532nm Ophthalmic Laser System used for Retinal Photocoagulation |
| 03700542625316 - SUPRA 577Y | 2021-04-21 577nm Ophthalmic Laser System used for Retinal Photocoagulation |