Identity
- Trade Name
- HR690XL applicator FDA UDI
- Generic Name
- Light-energy skin surface treatment system applicator FDA UDI
- Device Name
- IPL applicator indicated for the removal of unwanted hair and to effect stable long-term or permanent hair reduction for skin types I-IV. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen. FDA UDI
- Model / Reference
- AS120059 FDA UDI
- Description
- IPL applicator indicated for the removal of unwanted hair and to effect stable long-term or permanent hair reduction for skin types I-IV. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290016540444 FDA UDI
- 510(k) Number
- K153717 FDA UDI
- FDA Product Code
- ONF FDA UDI
- GMDN Term
- Light-energy skin surface treatment system applicator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 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
Yes
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
No
FDA UDI
Category: Light-energy skin surface treatment system applicator
HR690XL applicator by Venus Concept Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K153717 also covers:
- ACDUAL Light Block package — Venus Concept Inc.
- ACDUAL applicator — Venus Concept Inc.
- Diamondpolar applicator — Venus Concept Inc.
- HR 690XL Light Block package — Venus Concept Inc.
- HR650 applicator — Venus Concept Inc.
- HR650XL applicator — Venus Concept Inc.
- HR690 Light Block package — Venus Concept Inc.
- HR690 applicator — Venus Concept Inc.
- Octipolar applicator — Venus Concept Inc.
- SR515 applicator — Venus Concept Inc.
- SR580 applicator — Venus Concept Inc.
- Venus Versa - HR 650XL light block package — Venus Concept Inc.
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 II | Pending data |
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Manufacturer
- Manufacturer
- Venus Concept Inc.
Sources (1)
- FDA UDI bc6a568e-24f1-4c31-9036-b4daa1f3e7f1 34 fields · synced Jun 8, 2026