MedLite Laser System
by Continuum Biomedical, Inc. 2 variants
510(k) K955131
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK955131 | Date20 Feb 1996 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
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- Withdrawn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
Overview
AI-generated summary, 1 Oct 2026
The MedLite Laser System is a Powered Laser Surgical Instrument designed for dermatological and plastic surgical procedures. It delivers controlled laser energy for precise tissue ablation, coagulation, and pigment removal, including tattoo elimination and vascular lesion treatment. The device operates within the GEX classification, accommodating multiple specialty applications in powered laser surgery. Its design supports adjustable wavelength and pulse settings to optimize clinical outcomes across various dermatological indications.
The MedLite Laser System is supplied as a reusable medical device, intended for use in sterile surgical environments. It requires proper training for operation and adheres to FDA 510(k) clearance under the GEX product code, classified as Class II with Special Controls. Storage and handling must comply with manufacturer guidelines to maintain performance and safety. No explicit MRI safety information is provided, and its regulatory status is limited to the stated FDA clearance. No single-use or sterility assurances are noted beyond standard surgical device protocols.
Other devices from Continuum Biomedical, Inc.
Questions
AI-generated answers, 1 Oct 2026
What types of dermatological procedures is the MedLite Laser System designed for?
The MedLite Laser System is specifically engineered for dermatological and plastic surgical applications, including controlled tissue ablation, coagulation, and pigment removal. It is particularly effective for procedures like tattoo elimination and treatment of vascular lesions, offering adjustable wavelength and pulse settings to tailor outcomes for different clinical needs.
Is the MedLite Laser System reusable or single-use?
The MedLite Laser System is designed as a reusable medical device. It is intended for use in sterile surgical environments, requiring proper maintenance and adherence to manufacturer guidelines to ensure safety and performance over repeated uses.
What regulatory clearance does the MedLite Laser System hold?
The MedLite Laser System holds FDA 510(k) clearance under the GEX product code, classified as a Class II device with Special Controls. This clearance was granted in 1996 following a determination of substantial equivalence to a predicate device, with review by the General Plastic Surgery Advisory Committee.
Are there any special storage or handling requirements for the MedLite Laser System?
Yes, the MedLite Laser System must be stored and handled according to the manufacturer’s guidelines to preserve its performance and safety. While no explicit sterility assurances beyond standard surgical protocols are noted, proper cleaning, maintenance, and storage in a controlled environment are essential for reliable operation.
Does the MedLite Laser System have any known MRI safety information?
The MedLite Laser System does not provide explicit MRI safety information in its documentation. Clinicians should exercise caution and verify compatibility with their specific MRI equipment and protocols before use in an MRI environment.