Make an FDA 510(k) submission for a sebaceous hyperplasia indication for the CellFX System
Delivered after the deadline
AI-assessed · human review in progress Found and assessed by AI from the cited sources. Shown with its evidence; it is not counted in any Kept Score until confirmed.
- Announced
- 22 Feb 2021
- Due
- 31 Mar 2021
- Delivered
- December 2021
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“Continued preparation to make an FDA 510(k) submission for a sebaceous hyperplasia (SH) specific indication for the CellFX System as early as the end of the first quarter of 2021”
What we found
Evidence strength A What the grades mean
The company submitted the SH 510(k) in December 2021, about nine months after the end-Q1 2021 target. A November 2021 10-Q still described the submission as future.
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A Pulse Biosciences, Inc. 10-Q filed 2021-11-15
“This will require an additional 510(k) submission, as will each subsequent indication, and will likely be based on comparative clinical data.” ✓ confirmed on the page
-
A Pulse Biosciences, Inc. 10-K filed 2022-03-31
“In December 2021, we submitted a 510(k) to add the treatment of SH to the CellFX System’s indications for use in the United States.” ✓ confirmed on the page
Checked 26 Oct 2026.
Commitment DNA
The structured record of this commitment. Fields the company did not state are left blank rather than guessed.
- Event type
- Regulatory other
- Indicative materiality
- Medium rules
- Action
- Make
- Deliverable
- FDA 510(k) submission for sebaceous hyperplasia indication
- Where
- United States
- In the company’s control
- High
- Specificity
- Medium
How this entry was checked
- Commitment recordedThe company's words were matched word for word against the filing.
- First checkAn AI model, Claude (Anthropic), read the company's later filings and recorded the outcome with a quoted passage.
Not yet confirmed. Shown on the record, but it will not count in any score until it is confirmed. How verification works
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Report an error in this entry Reference: KI-C-2021-PLSE-024211 · Corrections policy