SL-100 Nd:YAG Laser for Urologic Surgery
510(k) K871516
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK871516 | Date9 Jul 1987 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LNK
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The SL-100 Nd:YAG Laser for Urologic Surgery is a Laser for Gastro-Urology Use, classified under FDA product code LNK. This device employs neodymium-doped yttrium aluminium garnet (Nd:YAG) laser technology to deliver precise, high-energy laser beams for surgical procedures in urology, including tissue ablation, coagulation, and lithotripsy. Its design supports minimally invasive interventions, reducing trauma to surrounding tissues while enabling targeted treatment of conditions such as benign prostatic hyperplasia (BPH) or ureteral strictures.
Intended for single-use in controlled clinical settings, the SL-100 is supplied as a sterile, disposable device requiring no special storage conditions beyond standard operating room protocols. It is classified as a Class II medical device under FDA regulations (21 CFR 878.4810) and holds a FDA 510K clearance (K871516) with a decision date of July 9, 1987. Compatibility with MRI environments is not specified, and the device must be handled in accordance with laser safety guidelines to ensure proper use and patient protection.
Other devices from Medical Energy, Inc.
Questions
AI-generated answers, 20 Sep 2026
What types of urologic procedures is the SL-100 Nd:YAG Laser specifically designed to assist with?
The SL-100 Nd:YAG Laser is designed for precise surgical interventions in urology, including tissue ablation, coagulation, and lithotripsy. This means it can be used for procedures like treating benign prostatic hyperplasia (BPH) or addressing ureteral strictures by delivering controlled laser energy to target tissues while minimizing damage to surrounding areas.
Is the SL-100 Nd:YAG Laser intended for reuse, or is it meant to be used only once?
The SL-100 Nd:YAG Laser is explicitly intended for single-use in controlled clinical settings. This design ensures patient safety and reduces the risk of contamination or device degradation from repeated use, aligning with standard sterile disposable medical device practices.
What storage requirements does the SL-100 Nd:YAG Laser have, and does it need special handling?
The SL-100 is supplied as a sterile, disposable device, so it does not require specialized storage conditions beyond those typically used in an operating room. Standard operating room protocols for sterile equipment should be followed, including protection from contamination and environmental hazards.
How was the SL-100 Nd:YAG Laser approved by the FDA, and what does that mean for its use?
The SL-100 received FDA 510(k) clearance (K871516) under the classification of a Class II medical device (21 CFR 878.4810) with a decision of *substantially equivalent* to a predicate device. This means it was determined to have the same intended use and technological characteristics as a previously cleared device, allowing it to be marketed legally for its specified urologic surgical applications.