Multipulse TM+1470
by Asclepion Laser Technologies GmbH
510(k) K133891
Multipulse TM+1470 is a medical device (FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument) made by Asclepion Laser Technologies GmbH, cleared under FDA 510(k) K133891 on 30 Jan 2015, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK133891 | Date30 Jan 2015 | StatusActive |
Official records
- FDA 510(k) database K133891
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GEX
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K133891
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Bare Fiber IR-Q 1000 2943 | 2943 | 04058784000569 | On the market | |
| Bare Fiber IR-Q 200 2940 | 2940 | 04058784000521 | On the market | |
| Bare Fiber IR-Q 400 2941 | 2941 | 04058784000538 | On the market | |
| Bare Fiber IR-Q 600 2942 | 2942 | 04058784000545 | On the market | |
| Bare Fiber IR-Q 800 2959 | 2959 | 04058784000552 | On the market | |
| Bare Fiber R IR-Q 1000 2807 | 2807 | 04058784000514 | On the market | |
| Bare Fiber R IR-Q 200 2806 | 2806 | 04058784000477 | On the market | |
| Bare Fiber R IR-Q 400 2867 | 2867 | 04058784000484 | On the market | |
| Bare Fiber R IR-Q 600 2866 | 2866 | 04058784000491 | On the market | |
| Bare Fiber R IR-Q 800 2961 | 2961 | 04058784000507 | On the market | |
| MultiPulse TM+1470 1901 | 1901 | 04058784000118 | On the market |
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Other devices filed under FDA product code GEX (Powered Laser Surgical Instrument).
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