Identity
- Trade Name
- SR515 applicator FDA UDI
- Generic Name
- Light-energy skin surface treatment system applicator FDA UDI
- Device Name
- • Treatment of benign pigmented epidermal and cutaneous lesions including: dyschromia, hyperpigmentation, melasma, ephelides (freckles), lentigines, nevi, melasma, and cafe-au-lait macules. • Treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of civatte, leg veins and venous malformations FDA UDI
- Model / Reference
- AS120033 FDA UDI
- Description
- • Treatment of benign pigmented epidermal and cutaneous lesions including: dyschromia, hyperpigmentation, melasma, ephelides (freckles), lentigines, nevi, melasma, and cafe-au-lait macules. • Treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of civatte, leg veins and venous malformations FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290016540390 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
SR515 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:
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- 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.
- HR690XL applicator — Venus Concept Inc.
- Octipolar 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 e1219314-8ce7-42aa-87e5-f06ccd604f09 34 fields · synced May 30, 2026