FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BTL-754
K Number: K241270
·
Decision Jan 30, 2025
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
17
Review Days
269
Basic Information
- Device Name
- BTL-754
- K Number
- K241270
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BTL Industries, Inc.
- Date Received
- May 6, 2024
- Decision Date
- January 30, 2025
- Product Code
- GEX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | FDA class 2 | General, Plastic Surgery |
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Other Clearances by BTL Industries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K243290 | BTL-785MJ | May 9, 2025 | Substantially Equivalent |
| K241516 | BTL-398 | Feb 10, 2025 | Substantially Equivalent |
| K242532 | BTL-785BNF-E | Dec 13, 2024 | Substantially Equivalent |
| K233849 | BTL-499 | Apr 23, 2024 | Substantially Equivalent |
| K233604 | BTL-785S | Mar 28, 2024 | Substantially Equivalent |
| K190456 | BTL 799-2L | Jul 5, 2019 | Substantially Equivalent |
| K190023 | BTL-084 | Mar 29, 2019 | Substantially Equivalent |
| K182363 | BTL-703 | Jan 24, 2019 | Substantially Equivalent |
| K180359 | BTL-FR2000 | Dec 13, 2018 | Substantially Equivalent |
| K181497 | HPM-6000UF | Nov 14, 2018 | Substantially Equivalent |