UltraClear
GUDID 00850039149009
Fractional Mid IR Fiber Laser System (Black/Black)
Acclaro Corporation
Dermatological solid-state laser system| Primary Device ID | 00850039149009 |
| NIH Device Record Key | 0213e787-8a24-4838-8d54-3fac6001d959 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | UltraClear |
| Version Model Number | AS-BB-00055 |
| Company DUNS | 105941754 |
| Company Name | Acclaro Corporation |
| 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 |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850039149009 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K210847
FDA Product Code
| GEX | Powered Laser Surgical Instrument |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00850039149009]
Moist Heat or Steam Sterilization
[00850039149009]
Moist Heat or Steam Sterilization
[00850039149009]
Moist Heat or Steam Sterilization
[00850039149009]
Moist Heat or Steam Sterilization
[00850039149009]
Moist Heat or Steam Sterilization
[00850039149009]
Moist Heat or Steam Sterilization
[00850039149009]
Moist Heat or Steam Sterilization
[00850039149009]
Moist Heat or Steam Sterilization
[00850039149009]
Moist Heat or Steam Sterilization
[00850039149009]
Moist Heat or Steam Sterilization
[00850039149009]
Moist Heat or Steam Sterilization
[00850039149009]
Moist Heat or Steam Sterilization
[00850039149009]
Moist Heat or Steam Sterilization
[00850039149009]
Moist Heat or Steam Sterilization
[00850039149009]
Moist Heat or Steam Sterilization
[00850039149009]
Moist Heat or Steam Sterilization
[00850039149009]
Moist Heat or Steam Sterilization
[00850039149009]
Moist Heat or Steam Sterilization
[00850039149009]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-04 |
| Device Publish Date | 2023-08-25 |
On-Brand Devices [UltraClear]
| 00850039149047 | Fractional Mid IR Fiber Laser System (Blue Metallic) |
| 00850039149030 | Fractional Mid IR Fiber Laser System (Purple Metallic) |
| 00850039149023 | Fractional Mid IR Fiber Laser System (Black) |
| 00850039149016 | Fractional Mid IR Fiber Laser System (White) |
| 00850039149429 | Fractional Mid IR Fiber Laser System (White Black) |
| 00850039149009 | Fractional Mid IR Fiber Laser System (Black/Black) |
Trademark Results [UltraClear]
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