AccessGUDID - DEVICE: Ulthera System Control Unit (00840763100223)

GUDID

Device Identifier (DI) Information

Brand Name: Ulthera System Control Unit
Version or Model: UC-1 Rev. I
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Ulthera, Inc.

Primary DI Number: 00840763100223
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 010981554 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
45591	Ultrasonic skin/body contouring system	An assembly of devices intended for the transdermal application of ultrasonic energy [e.g., high intensity focused ultrasound (HIFU)] to rupture subcutaneous fat cells to minimize the manifestation of cellulite, and/or to stimulate elastin/collagen production and tissue rejuvenation to improve the appearance of loose or wrinkled skin, and/or facial lines, for cosmetic purposes. The assembly typically consists of an electrically-powered generator, user controls/interface, and an ultrasonic transducer/handpiece; it may include a video imaging system to assist transducer positioning during treatment. This device may serve as a noninvasive outpatient procedure alternative to liposuction.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IYO	System, Imaging, Pulsed Echo, Ultrasonic
OHV	Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K134032	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a24f94bf-09a1-4926-92a3-3677a7b729e1
Public Version Date: June 30, 2025
Public Version Number: 5
DI Record Publish Date: September 07, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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