| Primary Device ID | 08800035500436 |
| NIH Device Record Key | 80a9714c-f7dc-437c-8496-bf17e2f744dc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HYPERION Gold Handpiece |
| Version Model Number | HYPERION Gold Handpiece |
| Company DUNS | 689856875 |
| Company Name | Laseroptek Co.,Ltd |
| 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 | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800035500436 [Primary] |
| GEX | Powered Laser Surgical Instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-02-06 |
| Device Publish Date | 2018-01-12 |
| 08800035500740 - HELIOS III body | 2025-04-04 HELIOS III body |
| 08800035500795 - HELIOS III Arm | 2025-04-04 HELIOS III Arm |
| 08800035500801 - HELIOS III Zoom Handpiece | 2025-04-04 HELIOS III Zoom Handpiece |
| 08800035500818 - HELIOS III 532 Handpiece | 2025-04-04 HELIOS III 532 Handpiece |
| 08800035500825 - HELIOS III 1064 Handpiece | 2025-04-04 HELIOS III 1064 Handpiece |
| 08800035500832 - HELIOS III Collimator Handpiece | 2025-04-04 HELIOS III Collimator Handpiece |
| 08800035500849 - HELIOS III User Manual | 2025-04-04 HELIOS III User Manual |
| 08800035500856 - HELIOS III Service Manual | 2025-04-04 HELIOS III Service Manual |