Identity
- Trade Name
- Wav30 FDA UDI
- Generic Name
- Radio-frequency skin contouring system applicator tip FDA UDI
- Model / Reference
- WAV30 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800016905090 FDA UDI
- 510(k) Number
- K241157 FDA UDI
- GMDN Term
- Radio-frequency skin contouring system applicator tip FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Radio-frequency skin contouring system applicator tip
Wav30 by CLASSYS Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radio-frequency skin contouring system applicator tip.
- triFX — POLLOGEN LTD · Class II
- triFX — POLLOGEN LTD · Class II
- INTRAgen Tip — Jeisys Medical Inc. · Class II
- Morpheus8 — Inmode MD , Ltd. · Class II
- Morpheus8 Prime 12 pin TIP — Inmode MD , Ltd. · Class II
- triFX — POLLOGEN LTD · Class II
- Thermage — Solta Medical, Inc. · Class I
- INTRAgen Tip — Jeisys Medical Inc. · Class II
Cleared under the same submission
K241157 also covers:
- MTR-AC-01 — CLASSYS Inc.
- MTR-AC-04 — CLASSYS Inc.
- MTR-AC-27G — CLASSYS Inc.
- Max-25 — CLASSYS Inc.
- Max-25C — CLASSYS Inc.
- Max-64C — CLASSYS Inc.
- Max-M25 — CLASSYS Inc.
- Max-M25C — CLASSYS Inc.
- QUADESSY Deeplus hand piece — CLASSYS Inc.
- QUADESSY Main Unit — CLASSYS Inc.
- QUADESSY Neutral hand piece — CLASSYS Inc.
- QUADESSY Set Package — CLASSYS 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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- CLASSYS Inc.
Sources (1)
- FDA UDI b4d38da2-d928-4117-a9f7-9770cc8490a0 33 fields · synced Jun 8, 2026