SkinStylus SteriLock MicroSystem (MP1209SL)— 510(k) K253002
Substantially EquivalentEsthetic Medical, Inc.
FDA 510(k) clearance K253002 for SkinStylus SteriLock MicroSystem (MP1209SL), Substantially Equivalent on 2026-02-19. Applicant: Esthetic Medical, Inc.. Device class: 2.
Summary
Esthetic Medical's SkinStylus SteriLock MicroSystem (MP1209SL) is filed under product code QAI, powered microneedle device. The record doesn't describe the system beyond its name and that code name.
Class II, 21 CFR 878.4430. General, Plastic Surgery is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Esthetic Medical filed from Long Beach, California. The decision came 153 calendar days after FDA received it (September 19, 2025 to February 19, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Esthetic Medical, Inc.
- Product code
- Product code QAI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4430
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Long Beach, CA, US
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